Treatment of postoperative pain should rely on results from randomized controlled trials and meta-analyses of high scientific quality. The efficacy of a particular intervention may depend on the type of surgical procedure, which supports the reporting of "procedure-specific" interventions. The aim of this systematic review was to document the procedure-specific evidence for analgesic interventions after total hip arthroplasty (THA). This PRISMA-compliant and PROSPERO-registered review includes randomized placebo-controlled trials (RCTs) of medication-based analgesic interventions after THA. Endpoints were postoperative opioid consumption, pain scores (rest and during mobilization), adverse events, and length of hospital stay. Fifty-eight trials with 19 different interventions were retrieved. High risk of bias, substantial differences in assessment-tools and criteria for pain, irregular reporting of adverse events, considerable differences in supplemental analgesic consumption, and basic analgesic regimens generally characterized trials. Meta-analyses of non-steroidal anti-inflammatory drugs, local infiltration analgesia, intrathecal opioids, and lumbar plexus block provided a 24-hour intravenous morphine-sparing effect of 14.1 (95 % confidence interval: 8.0-20.2) mg, 7.5 (3.7-11.3) mg, 19.8 (14.9-24.7) mg, and 11.9 (6.4-17.3) mg, respectively. Non-steroidal anti-inflammatory drugs and lumbar plexus block were demonstrated to provide reductions in postoperative pain scores. Intrathecal opioids increased pruritus, and lumbar plexus block reduced nausea and pruritus. The GRADE-rated quality of evidence ranged from low to very low throughout the analyses. This review demonstrated, that some analgesic interventions may have the capacity to reduce mean opioid requirements and/or mean pain intensity compared with controls, but the available randomized placebo-controlled trials does not allow a designation of a "best proven intervention" for THA.
IntroductionThe aim of this systematic review was to document efficacy, safety and quality of evidence of analgesic interventions after total knee arthroplasty (TKA).MethodsThis PRISMA-compliant and PROSPERO-registered review includes all-language randomized controlled trials of medication-based analgesic interventions after TKA. Bias was evaluated according to Cochrane methodology. Outcomes were opioid consumption (primary), pain scores at rest and during mobilization, adverse events, and length of stay. Interventions investigated in three or more trials were meta-analysed. Outcomes were evaluated using forest plots, Grading of Recommendations Assessment, Development and Evaluation (GRADE), L’Abbe Plots and trial sequential analysis.ResultsThe included 113 trials, investigating 37 different analgesic interventions, were characterized by unclear/high risk of bias, low assay sensitivity and considerable differences in pain assessment tools, basic analgesic regimens, and reporting of adverse events. In meta-analyses single and continuous femoral nerve block (FNB), intrathecal morphine, local infiltration analgesia, intraarticular injection of local anaesthetics, non-steroidal anti-inflammatory drugs, and gabapentinoids demonstrated significant analgesic effects. The 24-hour morphine-sparing effects ranged from 4.2 mg (CI: 1.3, 7.2; intraarticular local anaesthetics), to 16.6 mg (CI: 11.2, 22; single FNB). Pain relieving effects at rest at 6 hours ranged from 4 mm (CI: -10, 2; gabapentinoids), to 19 mm (CI: 8, 31; single FNB), and at 24 hours from 3 mm (CI: -2, 8; gabapentinoids), to 16 mm (CI: 8, 23; continuous FNB). GRADE-rated quality of evidence was generally low.ConclusionA low quality of evidence, small sample sizes and heterogeneity of trial designs prohibit designation of an optimal procedure-specific analgesic regimen after TKA.
Background: Sample size determination is essential for reliable hypothesis testing in clinical trials and should rely on adequate sample size calculations with alpha, beta, variance, and an effect size being the minimal clinically important difference (MCID). This facilitates interpretation of the clinical relevance of statistically significant results. No gold standard for MCIDs exists in postoperative pain research. Methods: We searched Cochrane Central Register of Controlled Trials, MEDLINE, and Embase for English language articles on randomised trials investigating analgesic interventions after total hip or knee arthroplasty. Primary outcomes were the reported MCIDs for pain score and cumulated rescue opioid consumption. Secondary outcomes included reported sample size calculations and propensity to report statistical significance without reaching MCID. Trend analyses were conducted using statistical process control. Results: We included 570 trials. Median MCID for 0-24 h opioid consumption was 10 mg i.v. morphine equivalents for absolute reductions (interquartile range [IQR]: 6.8-14.5) and relative 40% (IQR: 30e50%). Median MCIDs for pain scores were absolute 15 mm at rest (IQR: 10e20) and 18 mm during movement (IQR: 10e20) on a 0e100 mm VAS and relative 30% (IQR: 20e30%). No trends were demonstrated for MCIDs. Adequate sample size calculations were reported in 34% of trials. In 46% of trials with statistically significant primary outcomes, the differences did not reach the predetermined MCID. Conclusions: We provide clinician-perceived MCID estimates for rescue opioid consumption and pain scores that can be used for sample size calculations until reliable evidence-based patient-rated MCIDs emerge. Nearly half of the trials with significant findings did not reach the predetermined MCID.
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