Trial sequential analysis: adding a new dimension to meta‐analysis

Shah, Akshay; Smith, Andrew F

doi:10.1111/anae.14705

Cited by 69 publications

(60 citation statements)

References 24 publications

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“…The Sidik Jonkman random effects model, that is less likely to underestimate the heterogeneity between trials, was chosen to calculate the Z‐statistic, which is equal to the meta‐analysed intervention effect divided by its standard error. In cumulative meta‐analysis, adjusted significance testing has two objectives: first, to measure and account for the strength of the available evidence; and second, to control for the risk of type‐1 and type‐2 statistical errors occurring when repeated significance testing on accumulating data is performed 13. The strength of the available evidence can be considered by determining the required information size for a conclusive and reliable meta‐analysis.…”

Section: Methodsmentioning

confidence: 99%

Epidural vs. transversus abdominis plane block for abdominal surgery – a systematic review, meta‐analysis and trial sequential analysis

2020

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Traditionally, pain relief for abdominal surgery has centred on epidural analgesia, but transversus abdominis plane block is increasingly being used. Our aim was to compare the analgesic efficacy and the side-effect profile of transversus abdominis plane block with epidural analgesia in a systematic review with meta-analysis and trial sequential analysis. After a systematic search of the electronic databases, we identified 18 randomised controlled trials with 1220 patients. Confirmed by trial sequential analysis, our first co-primary outcome, postoperative pain score at rest at 12 h, was decreased by a mean difference (95%CI) of 0.69 (0.12-1.27; p = 0.02) with epidural analgesia compared with transversus abdominis plane block, with the quality of evidence graded as low. No difference was found for the second co-primary outcome, postoperative pain score at rest at 24 h, with the quality of evidence rated as very low. Relative to transversus abdominis plane block, epidural analgesia further reduced the need for intravenous morphine-equivalent consumption during the 0-24 h interval by a mean difference (95%CI) of 5.91 mg (2.34-9.49; p = 0.001) at the expense of an increased incidence of hypotension at 72 h, with a risk ratio (95%CI) of 5.88 (2.08-16.67; p < 0.001). Our meta-analysis was limited by detection and performance bias, significant statistical heterogeneity and publication bias. In view of the minimal clinically important difference in postoperative pain scores, epidural analgesia was interpreted to not be clinically different to transversus abdominis plane block after abdominal surgery. With transversus abdominis plane block, the increase in intravenous morphine-equivalent consumption at 24 h should be balanced against the decreased risk of hypotension at 72 h. In choosing between epidural analgesia and transversus abdominis plane block, potential benefits should be balanced against the reported risk of harm, although the confidence in the evidence varied, underlining the uncertainty in our estimates.

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Section: Methodsmentioning

confidence: 99%

Epidural vs. transversus abdominis plane block for abdominal surgery – a systematic review, meta‐analysis and trial sequential analysis

2020

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“…The risk of postoperative nausea was also reduced, with a risk ratio (95%CI) of 0.78 (0.67-0.91) (35 studies, 1903 participants).The quality of evidence was very low for most of these outcomes, however, and ultimately the authors concluded it was uncertain if "i.v. lidocaine, when compared to placebo or no treatment, has a beneficial impact on pain scores in the early postoperative phase, and on gastrointestinal recovery, postoperative nausea, and opioid consumption".The systematic reviews drew on a limited pool of small primary studies, and even taken together, the data are rather sparse[71,72]. They are similar, though, where they reflect the primary trials that they include, as patients who might be expected to be at greater risk of postoperative pain (those already taking analgesics or experiencing longterm pain) were not included.…”

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confidence: 99%

The use of intravenous lidocaine for postoperative pain and recovery: international consensus statement on efficacy and safety

et al. 2020

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Summary Intravenous lidocaine is used widely for its effect on postoperative pain and recovery but it can be, and has been, fatal when used inappropriately and incorrectly. The risk‐benefit ratio of i.v. lidocaine varies with type of surgery and with patient factors such as comorbidity (including pre‐existing chronic pain). This consensus statement aims to address three questions. First, does i.v. lidocaine effectively reduce postoperative pain and facilitate recovery? Second, is i.v. lidocaine safe? Third, does the fact that i.v. lidocaine is not licensed for this indication affect its use? We suggest that i.v. lidocaine should be regarded as a ‘high‐risk’ medicine. Individual anaesthetists may feel that, in selected patients, i.v. lidocaine may be beneficial as part of a multimodal peri‐operative pain management strategy. This approach should be approved by hospital medication governance systems, and the individual clinical decision should be made with properly informed consent from the patient concerned. If i.v. lidocaine is used, we recommend an initial dose of no more than 1.5 mg.kg‐1, calculated using the patient’s ideal body weight and given as an infusion over 10 min. Thereafter, an infusion of no more than 1.5 mg.kg‐1.h‐1 for no longer than 24 h is recommended, subject to review and re‐assessment. Intravenous lidocaine should not be used at the same time as, or within the period of action of, other local anaesthetic interventions. This includes not starting i.v. lidocaine within 4 h after any nerve block, and not performing any nerve block until 4 h after discontinuing an i.v. lidocaine infusion.

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“…This means that there was a conversion bias involved in the pooled results in this meta-analysis. Fourth, trial sequential analysis [ 50 ] could be utilized to examine the reliability of the results of this meta-analysis with a small sample size. Sixth, weighting bias may occur due to some small trials given disproportionately large weights.…”

Section: Discussionmentioning

confidence: 99%

A Meta-Analysis of Comparing Intermittent Epidural Boluses and Continuous Epidural Infusion for Labor Analgesia

Tzeng

Kao

Pan

et al. 2020

IJERPH

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With the development of medical equipment and techniques in labor anesthesia, it is a major issue to investigate the risks and treatment effects among techniques such as continuous epidural infusion (CEI) and intermittent epidural bolus (IEB). However, there is a controversial result regarding two techniques. This study was conducted through meta-analysis of randomized controlled trials (RCTs) for labor analgesia between the CEI and IEB techniques. The pooled results were presented as weighted mean differences (WMDs) together with 95% confidence intervals (CIs) and odds ratios (ORs) together with 95% CIs, respectively. Eleven RCTs were included in this meta-analysis. Four hundred sixty-five parturients accepted CEI, whereas 473 parturients accepted IEB labor analgesia. Elven identified low- risk bias studies were recruited for meta-analysis. The results presented no statistical difference in cesarean delivery rate between IEB and CEI (OR, 0.96; 95% CI, 0.67–1.37) and duration of second stage of labor (WMD, −3.82 min; 95% CI, −8.28 to 0.64). IEB had statistically significant lessened risk of instrumental delivery (OR, 0.59; 95% CI, 0.39–0.90) and for the use in local anesthetic (WMD, −1.71 mg bupivacaine equivalents per hour; 95% CI, −1.88 and −1.55). Accepted IEB had a higher score of maternal satisfaction (WMD, −6.95 mm; 95% CI, −7.77 to −6.13). Based on evidence, IEB showed a greater benefit for slightly reducing the use in local anesthetic, reduced risk of instrumental delivery, and improved maternal satisfaction for the requirement of labor epidural analgesia for healthy women. In the future, more studies need to be conducted to practice the IEB regimen and explore its influence on labor analgesia.

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Trial sequential analysis: adding a new dimension to meta‐analysis

Cited by 69 publications

References 24 publications

Epidural vs. transversus abdominis plane block for abdominal surgery – a systematic review, meta‐analysis and trial sequential analysis

Epidural vs. transversus abdominis plane block for abdominal surgery – a systematic review, meta‐analysis and trial sequential analysis

The use of intravenous lidocaine for postoperative pain and recovery: international consensus statement on efficacy and safety

A Meta-Analysis of Comparing Intermittent Epidural Boluses and Continuous Epidural Infusion for Labor Analgesia

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