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Cover of Evidence review for anaesthesia for knee replacement

Evidence review for anaesthesia for knee replacement

Joint replacement (primary): hip, knee and shoulder

Evidence review E

NICE Guideline, No. 157

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-3722-6

1. Anaesthesia for elective knee joint replacement

1.1. Review question: In adults having primary elective knee joint replacement, what is the clinical and cost effectiveness of regional anaesthesia or general anaesthesia, with or without nerve blocks and local infiltration analgesia, compared with each other or in combination?

1.2. Introduction

Total knee replacement surgery is painful. The anaesthetist and person undergoing surgery can choose from a number of interventions to prevent this.

Firstly there is a choice of underlying anaesthesia and the options are general anaesthesia, regional anaesthesia, or a combination of both. General anaesthesia is where the patient is put into a deep sleep. Regional anaesthesia is where only part of the body is anaesthetised, using local anaesthetic to ‘turn off’ the nerves temporarily – a nerve block. For the knee, this would typically be an injection of local anaesthetic into the fluid that surrounds the spine (a spinal anaesthetic) to numb both legs. During this time, the patient is typically aware of some pushing or pulling, but no pain.

Once it has been decided whether to use general, regional anaesthesia or both, then the technique or combination of techniques, needed to prevent pain after the operation should be considered. Preventing early pain is important in itself and, it is also recognised that reducing pain in the first few hours after surgery may help reduce pain over a longer period.

There are 2 supplementary anaesthetic options that can be utilised. Firstly local anaesthetic infiltration where a large volume of anaesthetic is injected it into the tissues around the operation site. This technique typically lasts for 8 to 10 hours. A second approach is to target an injection of anaesthetic to the nerves that supply the knee joint, often using an ultrasound machine to identify the nerve. Local anaesthetic infiltration and nerve blocks can be performed separately, or together.

This review seeks to determine the most clinically effective and cost-effective approach to both types of anaesthetic, and the type of supplementary anaesthetic options for total knee replacement.

1.3. PICO table

For full details see the review protocol in Appendix A:

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

1.4. Clinical evidence

1.4.1. Included studies

A search was conducted for trials comparing the effectiveness of intraoperative anaesthesia and analgesia routines utilised for knee joint replacement surgery.

Thirty-eight RCTs were included in the review;15, 17, 29, 37, 43, 51, 55, 86, 89, 95, 98, 104, 134, 135, 139, 176, 181, 185, 186, 201, 225, 227, 230, 232, 236, 244, 267, 273, 292–294, 300, 305, 307, 309–311, 317, 320 these are summarised in Table 2 below. The table has been divided into the 15 comparisons found in the evidence and studies with multiple comparisons feature multiple times. Evidence from these studies is summarised in the clinical evidence summary below (Table 3).

See also the study selection flow chart in Appendix C: study evidence tables in Appendix D: forest plots in Appendix E: and GRADE tables in Appendix H:

1.4.2. Excluded studies

See the excluded studies list in Appendix I:

1.4.3. Summary of clinical studies included in the evidence review

Table 2. Summary of studies included each comparison in the evidence review.

Table 2

Summary of studies included each comparison in the evidence review.

See Appendix D: for full evidence tables.

1.4.4. Quality assessment of clinical studies included in the evidence review

Table 3. Clinical evidence summary: Regional anaesthesia versus general anaesthesia.

Table 3

Clinical evidence summary: Regional anaesthesia versus general anaesthesia.

Table 4. Clinical evidence summary: Regional anaesthesia versus general anaesthesia with nerve block.

Table 4

Clinical evidence summary: Regional anaesthesia versus general anaesthesia with nerve block.

Table 5. Clinical evidence summary: Regional anaesthesia with LIA versus general anaesthesia with LIA.

Table 5

Clinical evidence summary: Regional anaesthesia with LIA versus general anaesthesia with LIA.

Table 6. Clinical evidence summary: Regional anaesthesia with nerve block versus general anaesthesia with nerve block.

Table 6

Clinical evidence summary: Regional anaesthesia with nerve block versus general anaesthesia with nerve block.

Table 7. Clinical evidence summary: General and regional anaesthesia versus general anaesthesia and nerve block.

Table 7

Clinical evidence summary: General and regional anaesthesia versus general anaesthesia and nerve block.

Table 8. Clinical evidence summary: Regional anaesthesia with LIA versus regional anaesthesia.

Table 8

Clinical evidence summary: Regional anaesthesia with LIA versus regional anaesthesia.

Table 9. Clinical evidence summary: Regional anaesthesia with nerve block versus regional anaesthesia.

Table 9

Clinical evidence summary: Regional anaesthesia with nerve block versus regional anaesthesia.

Table 10. Clinical evidence summary: Regional anaesthesia with LIA versus regional anaesthesia with nerve block.

Table 10

Clinical evidence summary: Regional anaesthesia with LIA versus regional anaesthesia with nerve block.

Table 11. Clinical evidence summary: Regional anaesthesia with nerve block and LIA versus regional anaesthesia with LIA.

Table 11

Clinical evidence summary: Regional anaesthesia with nerve block and LIA versus regional anaesthesia with LIA.

Table 12. Clinical evidence summary: Regional anaesthesia with nerve block and LIA versus regional anaesthesia with nerve block.

Table 12

Clinical evidence summary: Regional anaesthesia with nerve block and LIA versus regional anaesthesia with nerve block.

Table 13. Clinical evidence summary: General anaesthesia with LIA versus general anaesthesia.

Table 13

Clinical evidence summary: General anaesthesia with LIA versus general anaesthesia.

Table 14. Clinical evidence summary: General anaesthesia with nerve block versus general anaesthesia.

Table 14

Clinical evidence summary: General anaesthesia with nerve block versus general anaesthesia.

Table 15. Clinical evidence summary: General anaesthesia with LIA versus general anaesthesia with nerve block.

Table 15

Clinical evidence summary: General anaesthesia with LIA versus general anaesthesia with nerve block.

Table 16. Clinical evidence summary: General anaesthesia with nerve block and LIA versus general anaesthesia with LIA.

Table 16

Clinical evidence summary: General anaesthesia with nerve block and LIA versus general anaesthesia with LIA.

See Appendix F: for full GRADE tables.

1.5. Economic evidence

1.5.1. Included studies

One health economic study was identified with the relevant comparison and has been included in this review.170 The study is summarised in the health economic evidence profile below (Table 17) and the health economic evidence table in Appendix H: One original threshold analysis was conducted which can be found in Appendix I:

1.5.2. Excluded studies

No health economic studies that were relevant to this question were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in Appendix G:

1.5.3. Summary of studies included in the economic evidence review

Table 17. Health economic evidence profile: LAI in addition to a standard anaesthetic regimen versus standard anaesthetic regimen only.

Table 17

Health economic evidence profile: LAI in addition to a standard anaesthetic regimen versus standard anaesthetic regimen only.

1.5.4. Health economic modelling

A threshold analysis was conducted on the addition of nerve blocks to an anaesthetic regimen. The method and results of the analysis can be found in Appendix I:Nerve block threshold analysis. The analysis uses estimates of incremental cost to find what QALY or utility gain is required at a given threshold of cost effectiveness. The threshold selected for this analysis was £20,000 in line with the NICE reference case. A range of incremental costs driven by the time required to administer the nerve block (30 minutes, 10 minutes and 5 minutes) and if the cost of theatre time was incorporated (yes or no) were included in the analysis. The rationale for having theatre time included as a cost variable is that the committee suggested that if 2 anaesthetists are available a nerve block can be administered in the anaesthesia room, not incurring additional theatre time costs. Therefore, for scenarios where theatre time was not included, 2 consultant anaesthetists were costed in. Whereas when theatre time was included, only one consultant anaesthetist was costed in.

The results found that a nerve block is unlikely to be cost effective the longer it takes to administer, the shorter the effect duration, and if theatre time cost is included. However, there are circumstances, such as when administration time is short, effect duration is long and theatre time is not included, when a nerve block could be cost effective. The different combinations of these factors are present across the NHS, so nerve blocks may be a viable cost-effective anaesthetic intervention for some hospitals but not for others.

1.5.5. Unit costs

Table 18 shows the UK cost for the addition of a nerve block to any anaesthetic regimen when varying the time it takes to administer a nerve block and if the cost of theatre time is included or not.

Table 18. UK 2018 cost for the addition of a nerve block to an anaesthetic regimen for primary elective joint replacement when varying administration time and the inclusion of theatre time cost.

Table 18

UK 2018 cost for the addition of a nerve block to an anaesthetic regimen for primary elective joint replacement when varying administration time and the inclusion of theatre time cost.

1.6. Evidence statements

1.6.1. Clinical evidence statements

Thirty-eight RCTs covering 15 comparisons were included in the evidence review and relevant outcomes were extracted for 14 of the comparisons.

Regional anaesthesia versus general anaesthesia was compared in 2 RCTs (n=234) and all outcomes were graded at low or very low quality. No difference was found for mortality, 2 postoperative neurocognitive decline outcomes, thromboembolic complications, length of stay, and mobilisation. A benefit for general anaesthesia was seen in 2 other neurocognitive decline outcomes. No outcomes favoured regional anaesthesia.

Regional anaesthesia versus general anaesthesia with nerve block was compared in 1 RCT (n=99) and all outcomes were graded at low or very low quality. No difference was found for postoperative pain and length of stay. There was a benefit for general anaesthesia with nerve block in terms of mobilisation. No outcomes favoured regional anaesthesia.

Regional anaesthesia with LIA versus general anaesthesia with LIA was compared in 1 RCT (n=120) and 1 outcome graded moderate quality, 1 low quality and 2 at very low quality. No difference was found for thromboembolic complications, nausea, and mobilisation. There was a benefit for general anaesthesia with LIA in length of stay. No outcomes favoured regional anaesthesia with LIA.

Regional anaesthesia with nerve block versus general anaesthesia with nerve block was compared in 1 RCT (n=94) and 1 outcome graded high quality and 2 moderate quality. No outcomes indicated a benefit of either treatment and these were postoperative pain, length of stay, and mobilisation.

General with regional anaesthesia versus general anaesthesia and nerve block was compared in 2 RCTs (n=126) and all outcomes graded very low quality. There was a benefit for general with regional anaesthesia in postoperative pain. Nausea and mobilisation outcomes indicated a benefit of general anaesthesia and nerve block.

Regional anaesthesia with LIA versus regional anaesthesia was compared in 8 RCTs (n=686) and all but 1 outcome was graded very low quality. There was a benefit for regional anaesthesia with LIA in 1 postoperative pain outcome (1 RCT), hospital readmission, and 1 postoperative use of analgesia outcome (1 RCT). No difference was seen for a second postoperative pain outcome (6 RCTs), thromboembolic complications, a second postoperative use of analgesia outcome (6 RCTs), length of stay, and nausea. No outcomes favoured regional anaesthesia alone.

Regional anaesthesia with nerve block versus regional anaesthesia were compared in 4 RCTs (n=292) and quality ranged from high to low. A benefit was seen for regional anaesthesia with nerve block in terms of 2 postoperative pain outcomes, postoperative use of analgesia, and mobilisation. There was no difference between interventions in length of stay and nausea. No outcomes favoured regional anaesthesia alone.

Regional anaesthesia with LIA versus regional anaesthesia with nerve block were compared in 8 RCTs (n=736) and quality ranged from moderate to very low. A benefit for regional anaesthesia with nerve block was found for 1 postoperative pain outcome (1 RCT), hospital readmissions, and nausea. Regional anaesthesia with LIA was more effective for thromboembolic complications. There was no difference for a second postoperative pain outcome (4 RCTs), 2 postoperative use of analgesia outcomes, and length of stay.

Regional anaesthesia with nerve block and LIA versus regional anaesthesia with LIA were compared in 4 RCTs (n=427) and quality ranged from moderate to very low. Regional anaesthesia with nerve block and LIA were more effective in a postoperative pain outcome (3 RCTs). All other outcomes indicated no clinical difference between interventions, these was a second postoperative pain outcome (1 RCT), postoperative use of analgesia, length of stay, nausea, and mobilisation.

Regional anaesthesia with nerve block and LIA versus regional anaesthesia with nerve block alone were compared in 5 RCTs (n=343) and quality ranged from moderate to very low. 4 of 5 outcomes indicated a benefit of using regional anaesthesia with nerve block and LIA, these were postoperative pain, postoperative use of analgesia, nausea, and mobilisation. There was no clinical difference between interventions in terms of length of stay.

General anaesthesia with LIA versus general anaesthesia were compared in 1 RCT (n=48) and quality was graded low or very low for all outcomes. There was a clinically important benefit for general anaesthesia in thromboembolic complications. Length of stay and nausea did not find any difference between interventions. No outcomes favoured general anaesthesia with LIA.

General anaesthesia with nerve block versus general anaesthesia were compared in 1 RCT (n=107) and both outcomes were graded very low quality. General anaesthesia with nerve block was found to be more effective for postoperative use of analgesia however no difference was found for postoperative pain. No outcomes favoured general anaesthesia alone.

General anaesthesia with LIA versus general anaesthesia with nerve block were compared in 3 RCTs (n=175) and outcomes were graded low or very low quality. General anaesthesia with LIA was found to be more effective in terms of length of stay. The other 2 outcomes found no difference between interventions; these were postoperative use of analgesia and mobilisation.

General anaesthesia with nerve block and LIA versus general anaesthesia with LIA were compared in 3 RCTs (n=161) though only 1 RCT (n=55) provided outcomes and these were all graded very low quality. A benefit for general anaesthesia with nerve block and LIA was found for postoperative use of analgesia. No difference between interventions was found for postoperative pain and thromboembolic complications. No outcomes favoured general anaesthesia with LIA.

General anaesthesia with nerve block and LIA versus general anaesthesia with nerve block were compared in 2 RCTs (n=100). However no relevant outcomes could be extracted.

1.6.2. Health economic evidence statements

One cost utility analysis found that using local anaesthetic wound infiltration in addition to a femoral nerve block and regional or general anaesthesia was dominant (less costly and more effective) compared to femoral nerve block, regional or general anaesthesia alone in people undergoing total knee replacement. This analysis was assessed as partially applicable with potentially serious limitations.

One original threshold analysis for the addition of a nerve block to any anaesthetic regimen found that nerve blocks are unlikely to be cost effective if theatre time is included in the incremental cost or if administration time is longer. However, it is possible the addition of a nerve block is cost effective if administration time is short, the cost of theatre time is not included and if the duration of effect used in the analysis is longer. The cost of theatre time can be excluded when there are two anaesthetists present so that the nerve block can be administered in the anaesthesia room, therefore not taking up extra theatre time.

1.7. The committee’s discussion of the evidence

1.7.1. Interpreting the evidence

1.7.1.1. The outcomes that matter most

The critical outcomes agreed by the guideline committee were mortality, quality of life, postoperative pain, postoperative neurocognitive decline, thromboembolic complications, and hospital readmission. The time point for mortality, the most critical outcome, was specified as within 90 days because the committee were concerned that there are confounding factors that will not be adequately resolved over longer time periods. There are many factors outside of anaesthetic utilised during joint replacement surgery that contribute towards mortality and these expand as a person moves further on in their life. The committee were aware the trials would not be of an adequate size to equalise these factors between treatment groups. Postoperative pain is of critical importance as it represents a central aspect person’s initial experience of the joint replacement surgery. In addition the committee agreed that there is an argument that acute pain is a predictor of chronic pain and therefore reducing postoperative pain reduces future chronic pain. Postoperative neurocognitive decline is a key decision making outcome for the people undergoing joint replacement surgery. The committee anaesthetist said that neurocognitive decline was a major concern highlighted by people when these decision making conversations occur.

Important outcomes are postoperative use of analgesia, length of stay, nausea, and mobilisation within 24 hours after surgery. Postoperative use of analgesia is an indirect indicator of postoperative pain and as such is a useful measure for anaesthetic approach. Reduced length a very important to those undergoing surgery and has economic implications. The anaesthetic approach may impact when a person can mobilise themselves. A person’s ability mobilise themselves shortly after surgery represents the early experience of a knee joint replacement and also whether they can be discharged from hospital.

1.7.1.2. The quality of the evidence

The overall outcome quality ranged from high to very low though the great majority were assessed as low or very low quality.

The outcome quality was often downgraded due to risk of bias because studies that did not state an adequate method of randomisation or gave an adequate description of allocation concealment. A further reason for downgrading quality due to risk of bias was due to the difficulty of blinding in surgical treatment which meant subjective outcomes were occasionally assessed by people who knew the anaesthetic treatment utilised. Outside of those some studies had missing data and were downgraded for that.

More than half of the outcomes were downgraded in quality due to imprecision and more than ten percent was downgraded for inconsistency. This was not explained by subgroup analysis and a random effects model was utilised.

1.7.1.3. Benefits and harms

36 randomised controlled trials were included in the evidence review. These trials encompassed 15 comparisons though relevant evidence was only found for 14 of the comparisons. The studies investigating the 15th comparison did not provide relevant outcomes for analysis. A network meta-analysis was considered for this analysis but there were no suitable outcomes reported across the comparisons to facilitate this approach. Many studies were excluded as it was unclear if the knee arthroplasty being undertaken was primary arthroplasty. The committee agreed that revision surgery is different enough from primary arthroplasty that studies where primary arthroplasty was not specified should be excluded. A number of studies were excluded due to nerve block being utilised in the postoperative period and the protocol for this evidence review states that only LIA can be started in the postoperative period.

The committee commented that most of the studies included in the review concentrated on comparisons involving regional anaesthesia in both treatment groups. There were many fewer studies comparing general anaesthesia in both groups or regional anaesthesia to general anaesthesia. It was suggested that having relatively few studies for those comparisons may have led to the less definitive results.

The committee spoke about the results of comparisons involving nerve block in the treatment. Many of the studies utilised femoral nerve blocks (FNB) but modern care has shifted towards Adductor Canal Blocks (ACB). FNBs and other nerve blocks that have a motor component are thought to make early mobilisation more difficult and consequently lead to a longer length of stay. The committee specified nerve blocks that do not impair motor function in their recommendation. For example ACBs only block sensory nerves and this could lead to faster recovery. The committee agreed that the use of FNBs could have negatively biased the results in length of stay and mobilisation outcomes unfairly given the modern prominence of ACBs and the results should be interpreted with that in mind.

The committee agreed that the results of the review did not distinguish either regional anaesthesia or general anaesthesia from the other. There was little evidence for using a combination of the two and it is rarely used this way in NHS practice. Therefore a recommendation was made to offer either regional anaesthesia or general anaesthesia for primary elective total knee replacements. However the results within the regional anaesthesia with or without augmentation versus regional anaesthesia with or without augmentation comparisons indicated benefits with the addition of a nerve block or LIA. Additionally it indicated that adding both nerve block and LIA on top of regional anaesthesia was more effective than offering regional with either one alone. The results for general anaesthesia with or without augmentation versus general anaesthesia with or without augmentation were less clear cut. The committee commented that where the results favoured one treatment, it was in all but one case the treatment with the combination treatment with LIA and/or nerve block. However the majority of the results indicated no clinical difference between the treatments. The committee agreed that it was important to leave room in the recommendations for the anaesthetist to use their expertise and experience to modify the anaesthesia and analgesia where it makes clinical sense.

1.7.2. Cost effectiveness and resource use

The evidence presented showed that the addition of LIA to a nerve block and regional or general anaesthesia was cost effective. The cost savings in the economic evidence were driven by reduced costs of inpatient admissions after initial discharge in the LAI group. There was consensus that using LIA is likely to represent minimal costs in terms of time or personnel as it is often administered in redundant theatre time. However, the committee thought the evidence was limited given that there was no sub-group analysis for those who received general or regional anaesthesia. The cost savings or health gains could have been driven by either of these groups. There was no economic evidence presented for the addition of a nerve block to an anaesthetic regimen. Current practice is varied; some surgeons will only offer LAI in addition to general or regional whereas others will only offer nerve blocks in addition to general or regional.

For general anaesthesia using a volatile agent is cheaper than using total intravenous anaesthesia (TIVA), although the quality of recovery may be reduced. There are myriad factors, aside from the agents themselves, which can affect the overall cost of anaesthesia. However, it was agreed that regional anaesthesia is likely to be less costly than general anaesthesia. Despite this, general anaesthesia should still be available for those who are contraindicated for regional anaesthesia.

The intervention in the included study factored in a femoral nerve block. However, standard practice of nerve blocks, if used, has now moved away from femoral nerve blocks to adductor canal blocks. An adductor canal block may take up to 5 minutes of additional theatre time for those who are familiar with the procedure. There may be further additional time required initially for those who are not familiar with using nerve blocks. Some members of the committee shared experience of nerve block administration time being as high as 45 minutes, although this would be a rarity. The unit cost of £14.22 per minute for theatre time (including implant cost, personnel, overheads, consumables and facilities) presented from the economic evidence was thought to be very low; a more realistic unit cost of theatre time would be around £20.50 as included in CG124.

Given the lack of evidence and uncertainty surrounding the augmentation of an anaesthetic regimen with nerve blocks, a threshold analysis was conducted. The analysis showed what gain in quality adjusted life years (QALY) and health related quality of life (HRQoL) is necessary for an anaesthetic regimen augmented with nerve block to be cost effective at a threshold of £20,000 per QALY. Three factors highlighted by the committee as variable across the NHS were explored in the analysis. These factors were the time it takes to administer the nerve block (5 minutes, 10 minutes and 30 minutes); the length of time that the nerve block has an effect for (24 hours, 3 days, 10 days and 30 days); and if the cost of theatre time should be included or not. The rationale for having theatre time included as a cost variable was that the committee suggested that if 2 anaesthetists are available a nerve block can be administered in the anaesthesia room, not incurring additional theatre time costs. Therefore, for scenarios where theatre time was not included, 2 consultant anaesthetists were costed in. Whereas when theatre time was included, only one consultant anaesthetist was costed in.

Outlined below is the QALY gain needed based on the time taken to administer the nerve block and whether or not theatre time was included:

  • Administration time 30 minutes with theatre time: 0.034
  • Administration time 10 minutes with theatre time: 0.012
  • Administration time 5 minutes with theatre time: 0.006
  • Administration time 30 minutes with no theatre time: 0.006
  • Administration time 10 minutes with no theatre time: 0.002
  • Administration time 5 minutes with no theatre time: 0.002

The gain in HRQoL necessary at range of time horizons for all scenarios listed in the bullet points above was calculated (24 hours, 3 days, 10 days and 30 days). The results indicated that for a number of scenarios; particularly when the time to administer was 30 minutes, the intervention effect was 24 hours and when the cost of theatre time was included; the likelihood of nerve blocks being cost effective was impossible given that the gain in HRQoL needed was greater than 1 (given the assumed scale ranges from 0 to 1). When the assumptions were softened to their respective middle values, the gain in HRQoL was often not impossible (the gain needed was less than 1) but improbable. Finally, when time to administer was 5 minutes, the intervention effect was 30 days and when theatre time was excluded, the gain in HRQoL and therefore cost-effectiveness was more realistic.

The committee acknowledged that the time required for administration and the inclusion of the cost of theatre time was dependent on the experience of the anaesthetist and if two anaesthetists are available, respectively. All combinations of personnel numbers and time taken for administration can be found on the NHS at present. The length of time that nerve blocks have an effect could be argued to be anything between a matter of hours to a lifetime. The analgesic effect of a nerve block is variable but may be 8 hours on average for knee replacements. However, a 24 hour time horizon may be the most appropriate when considering acute post-operative outcomes (for example, pain, post-operative nausea and vomiting). A longer effect duration of 10 days to 30 days may be most appropriate to account for the possible effect of anaesthetic choice on adverse clinical outcomes (for example post-operative morbidity and mortality). Lastly, an even longer time horizon would be needed to account for long term outcomes (such as chronic pain, opioid dependence and range of motion).

The committee agreed that there is clinical benefit to the addition of nerve blocks, although they are only likely to be cost effective when administered by an experienced anaesthetist, theatre time is not included (so two anaesthetists are present) and when the effect duration is longer. The circumstances when nerve blocks are cost effective may be found in some hospitals but not in others.

Due to evidence suggesting that the addition of LIA to regional or general anaesthesia is clinically effective and likely to be cost effective, a recommendation was made offering this combination of anaesthesia. As the committee thought there may be a clinical benefit when adding a nerve block on top of LIA to regional or general anaesthesia, but concerns remained regarding the cost effectiveness, a weaker recommendation was made to consider the use of a nerve block in addition to LIA and regional or general anaesthesia. There were roughly 84,000 total knee replacements in 2017, all of which require some form of anaesthetic. All orthopaedic units currently offer a choice of general or regional anaesthesia. Most augment this with either LIA or a nerve block or both. Although the cost of nerve blocks varies, it is not expected that services currently offering LIA will change to nerve blocks. This recommendation is unlikely to lead to significant change from current practice.

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Appendices

Appendix B. Literature search strategies

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.195

For more detailed information, please see the Methodology Review.

B.1. Clinical search literature search strategy

Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the searches where appropriate.

Table 21. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

Cochrane Library (Wiley) search terms

Epistemonikos search terms

B.2. Health Economics literature search strategy

Health economic evidence was identified by conducting a broad search relating to the joint replacement population in NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional health economics searches were run in Medline and Embase.

Table 22. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

NHS EED and HTA (CRD) search terms

Appendix D. Clinical evidence tables

Download PDF (927K)

Appendix E. Forest plots

E.12. General anaesthesia with nerve block versus general anaesthesia

Figure 58. Postoperative pain up to 30 days

Figure 59. Postoperative use of analgesia

Appendix F. GRADE tables

Table 23. Clinical evidence profile: Regional anaesthesia versus general anaesthesia

Table 24. Clinical evidence profile: Regional anaesthesia versus general anaesthesia with nerve block

Table 25. Clinical evidence profile: Regional anaesthesia with LIA versus general anaesthesia with LIA

Table 26. Clinical evidence profile: Regional anaesthesia with nerve block versus general anaesthesia with nerve block

Table 27. Clinical evidence profile: General and regional anaesthesia versus general anaesthesia and nerve block

Table 28. Clinical evidence profile: Regional anaesthesia with LIA versus regional anaesthesia

Table 29. Clinical evidence profile: Regional anaesthesia with nerve block versus regional anaesthesia

Table 30. Clinical evidence profile: Regional anaesthesia with LIA versus regional anaesthesia with nerve block

Table 31. Clinical evidence profile: Regional anaesthesia with nerve block and LIA versus regional anaesthesia with LIA

Table 32. Clinical evidence profile: Regional anaesthesia with nerve block and LIA versus regional anaesthesia with nerve block

Table 33. Clinical evidence profile: General anaesthesia with LIA versus general anaesthesia

Table 34. Clinical evidence profile: General anaesthesia with nerve block versus general anaesthesia

Table 35. Clinical evidence profile: General anaesthesia with LIA versus general anaesthesia with nerve block

Table 36. Clinical evidence profile: General anaesthesia with nerve block and LIA versus general anaesthesia with LIA

Appendix H. Health economic evidence tables

Download PDF (182K)

Appendix I. Nerve block threshold analysis

A threshold analysis was conducted in order to determine the likelihood of the addition of nerve block to any anaesthetic regimen being cost effective. The analysis was deemed necessary by the committee given the lack of health economic evidence about the addition of nerve block.

I.1. Method

The analysis uses estimates of incremental cost to find what QALY or health related quality of life (HRQoL) gain is required at a given threshold of cost effectiveness. The threshold selected for this analysis was £20,000 in line with the NICE reference case. A range of incremental costs (see Table 37) driven by the time required to administer the nerve block (30 minutes, 10 minutes and 5 minutes) and if the cost of theatre time was incorporated (yes or no) were included in the analysis. The rationale for having theatre time included as a cost variable was that the committee suggested that if 2 anaesthetists are available a nerve block can be administered in the anaesthesia room, not incurring additional theatre time costs. Therefore, for scenarios where theatre time was not included, 2 consultant anaesthetists were costed in. Whereas when theatre time was included, only one consultant anaesthetist was costed in. The time required to administer a nerve block reflected the experience of the staff member in giving it, a quicker time equates to a more experienced staff member. These factors were investigated in line with the committee’s agreement that they were variable in current practice. Other resources used for nerve block administration were taken from CG124196 and agreed by the committee.

The different incremental cost estimates were substituted into the equation for the incremental cost-effectiveness ratio (ICER). The equation was then rearranged (see equation below) to find the incremental QALY gain needed for the nerve block intervention to be cost effective at £20,000.

ICER=Incremental costs÷Incremental QALY

Therefore:

Incremental QALY=Incremental costs÷ICER

Following this an additional factor was analysed that was deemed variable by the committee; the time that nerve blocks have an effect upon people. The committee suggested that it could be argued the effect ranges from a matter of hours to a lifetime. The analgesic effect of a nerve block is variable but may be 8 hours on average for knee replacements. However, a 24 hour time horizon may be the most appropriate when considering acute post-operative outcomes (for example, pain, post-operative nausea and vomiting). A longer duration of effect of 10 days to 30 days may be most appropriate to account for the possible effect of anaesthetic choice on adverse clinical outcomes (for example post-operative morbidity and mortality). Lastly, an even longer time horizon would be needed if it is considered that nerve blocks have an effect upon longer term outcomes (such as chronic pain, opioid dependence and range of motion). However, in line with the pain score outcome included in the protocol, the maximum effect horizon included in the analysis was 30 days. The different QALY gains calculated as outlined above were then substituted into the QALY equation with the different time horizons (24 hours, 3 days, 10 days and 30 days). The equation was then rearranged to find the gain in HRQoL gain needed to be cost effective at a threshold of £20,000 under each scenario.

Incremental QALY=Incremental life years gained×Incremental utility(HRQoL)

Therefore:

Incremental utility(HRQoL)=Incremental QALY÷Incremental life years gained

If the requisite HRQoL gain was greater than 1, then it was deemed not possible for the addition of nerve blocks to be cost effective under that scenario. The assumed scale of health related quality of life was 0 to 1 where 1 is the maximum health related quality of life and 0 the least. This was chosen as the NICE Reference case states to use the EQ-5D instrument that also uses a 0 to 1 scale. The smaller the gain needed in HRQoL, the more likely the addition of nerve block was to be cost effective.

Table 37 shows the unit costs used to calculate the cost for the addition of a nerve block to an anaesthetic regimen for a the different scenarios likely to represent current practice ion the NHS

Table 37. UK 2018 cost for the addition of a nerve block to an anaesthetic regimen for primary elective joint replacement when varying administration time and the inclusion of theatre time cost

I.2. Results

The gain in QALY and gain in HRQoL needed under a range of different scenarios is shown in Table 38. For a number of scenarios; particularly when the time to administer was 30 minutes, the duration of effect was 24 hours and when theatre time was included; the likelihood of nerve blocks being cost effective was impossible given that the gain in HRQoL needed was greater than 1. When the assumptions were softened to the middle values, the gain in HRQoL was often not impossible (the gain needed was less than 1) but improbable. Finally, when time to administer was 5 minutes, the intervention effect was 30 days and when theatre time was excluded, the gain in HRQoL and therefore cost-effectiveness was more realistic.

Table 38. Threshold analysis results

I.3. Conclusions

The results indicated that for some scenarios it is impossible for nerve blocks to be cost effective, for others cost effectiveness is improbable, whilst for some it is possible.

The committee agreed that there is clinical benefit to the addition of nerve blocks, although they are only likely to be cost effective when administered by an experienced anaesthetist (leading to reduced administration time), theatre time is not included (so two anaesthetists are present) and the duration of effect is longer (as discussed, the most appropriate duration of effect is arguable). The circumstances when nerve blocks are cost effective may be found in some hospitals but not in others. Therefore the committee decided on a recommendation to consider the addition of a nerve block to LIA and regional or general anaesthesia.

Appendix J. Excluded studies

J.2. Excluded health economic studies

Studies that meet the review protocol population and interventions, and the economic study inclusion criteria but have not been included in the review based on applicability and/or methodological quality are summarised below with reasons for exclusion.

Table 40. Studies excluded from the health economic review

Appendix K. Research recommendations

K.1. Anaesthesia for hip or knee replacement

Research question: What is the clinical and cost effectiveness of adding a nerve block to regional or general anaesthesia, in combination with LIA, for primary elective knee replacements?

Why this is important:

In 2017, there were 108,000 knee replacements performed in the UK, at a cost of over £1Billion to the NHS. These are painful operations, with prolonged recovery times. Better pain relief after surgery is good for patients, may reduce the need for opiates after surgery with their consequent side effects, and may improve rehabilitation and reduce the time spent in hospital. Also, there is some evidence that better pain relief after surgery reduces long term pain after surgery.

One commonly used method for reducing pain after surgery is for the anaesthetist to inject local anaesthetic around some of the nerves that supply the joint, this is called a nerve block. Although the equipment is cheap, performing a nerve block may take up theatre time which can be expensive. There is a small risk of nerve injury, although this is rare. While the NICE review suggested the addition of a nerve block was clinically effective and could be cost effective for knee replacement, there was some uncertainty.. Local anaesthetic infiltration (LIA) by the surgeon is cheaper, but the use of a block may have benefits over and above that. The relevance of this question to a large number of people, the potential benefit of reducing pain balanced against the potential cost, and the wide variation in practice around the UK, meant that the committee considered this to be a high priority research question.

Criteria for selecting high-priority research recommendations

Final

Intervention evidence review underpinning recommendation 1.3.2 and the research recommendation in the NICE guideline

This evidence review was developed by the National Guideline Centre, hosted by the Royal College of Physicians

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.

Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Copyright © NICE 2020.
Bookshelf ID: NBK561390PMID: 32881458

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