Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial

Paul, James; Nantha-Aree, Manyat; Buckley, Norman; Cheng, Ji; Thabane, Lehana; Tidy, Antonella; DeBeer, Justin; Winemaker, Mitchell; Wismer, David; Punthakee, Dinshaw; Avram, Victoria

doi:10.1007/s12630-013-9902-1

Cited by 61 publications

(85 citation statements)

References 26 publications

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“…This may require days or even weeks of titration to target dosage with such medications as duloxetine, gabapentin, or pregabalin. Many prevention studies for CPSP have initiated gabapentin and other oral medications between 1 hour and 1 day prior to surgery [3,12,24,25,27,33,51,52,57,66,95,97,98,101,108,116,131,133,147,148,165]. One study initiated treatment with an antidepressant 2-3 weeks prior to coronary artery bypass surgery; however, chronic pain was only assessed as part of a composite quality of life measure [31].…”

Section: Design Considerations In the Context Of 4 Illustrative Prmentioning

confidence: 99%

Research design considerations for chronic pain prevention clinical trials

Gewandter

Dworkin

Turk

et al. 2015

Pain

131

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Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (i.e., chronic post-surgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (i.e., surgery, viral infection, injury, and toxic/noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

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Section: Design Considerations In the Context Of 4 Illustrative Prmentioning

confidence: 99%

Research design considerations for chronic pain prevention clinical trials

Gewandter

Dworkin

Turk

et al. 2015

Pain

131

View full text Add to dashboard Cite

show abstract

“…Eight trials were classified as overall low risk of bias, [39, 43, 46, 56, 59, 72, 73, 85] 18 trials were overall unclear risk of bias [21, 23, 24, 26, 28, 29, 31, 36, 38, 42, 52, 54, 55, 61, 65, 66, 68, 69, 80] and 48 trials were classified as high risk of bias, [20, 22, 25, 27, 30, 32–35, 37, 40, 41, 44, 45, 47–51, 53, 57, 58, 60, 62–64, 67, 70, 71, 74–79, 81–84, 86–94] (Fig. 2: Bias assessment).…”

Section: Resultsmentioning

confidence: 99%

Gabapentin in procedure-specific postoperative pain management – preplanned subgroup analyses from a systematic review with meta-analyses and trial sequential analyses

et al. 2017

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BackgroundIt has been argued that postoperative pain treatment should be “procedure-specific”, since different analgesics may have specific effects dependent on the surgical procedure. The aim of the present subgroup analysis was to compare the beneficial and harmful effects of perioperative gabapentin treatment in different surgical procedures.MethodsRelevant databases were searched for randomized clinical trials (RCTs) comparing gabapentin versus placebo. Two authors independently screened titles and abstracts, extracted data and assessed risk of bias. The primary outcomes were differences in 24-h morphine consumption, and serious adverse events (SAE) between surgical procedures. These subgroup analyses were predefined in a PRISMA compliant systematic review registered at PROSPERO (ID: CRD42013006538). It was predefined that conclusions should primarily be based on trials classified as overall low risk of bias.ResultsSeventy-four RCTs with 5645 patients were included, assessing benefit and harm in cholecystectomy, hysterectomy, mastectomy, and arthroplasty surgery, spinal surgery, and thoracic surgery.Only eight of 74 trials were classified as overall low risk of bias limiting our ability to conclude on the estimates in most meta-analyses. The differences between surgical procedures in these trials were not statistically significant when tested for subgroup differences. Fifteen trials with 1377 patients reported a total of 59 SAEs, most of which were observed in the thoracic surgery group.ConclusionBoth beneficial and harmful effects in these subgroup analyses were influenced by bias and insufficient data, limiting conclusions. With these limitations, we could not adequately test for differences in beneficial or harmful outcomes between six surgical subgroups undergoing perioperative gabapentin treatment.Electronic supplementary materialThe online version of this article (doi:10.1186/s12871-017-0373-8) contains supplementary material, which is available to authorized users.

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“…Empirical data from The Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study (MOBILE trial)20 was used to demonstrate the performance of different baseline adjustment methods and their effect on the statistical comparison. The statistical properties of covariate adjustments were examined in terms of several aims, including: 1) the direction of the treatment difference; 2) the magnitude of the treatment difference; and 3) the precision of the treatment difference 9,10…”

Section: Methodsmentioning

confidence: 99%

“…In a single-center, blinded, randomized, placebo-controlled study, 102 patients were randomized to receive either gabapentin or placebo, in addition to standard of care, 2 hours before undergoing total knee arthroplasty 20. Morphine consumption at 72 hours was the primary end point of the trial.…”

Section: Methodsmentioning

confidence: 99%

“…To compare methods, previously reported outcome data20 (flexion range of motion) was analyzed using ANCOVA and the other three methods outlined above. The robustness of the latter three methods was evaluated by qualitatively comparing the direction and magnitude of effect, the precision of the estimate, and the ease of interpretation of the results.…”

Section: Introductionmentioning

confidence: 99%

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Empirical comparison of four baseline covariate adjustment methods in analysis of continuous outcomes in randomized controlled trials

Zhang¹,

Paul²,

Nantha-Aree³

et al. 2014

CLEP

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BackgroundAlthough seemingly straightforward, the statistical comparison of a continuous variable in a randomized controlled trial that has both a pre- and posttreatment score presents an interesting challenge for trialists. We present here empirical application of four statistical methods (posttreatment scores with analysis of variance, analysis of covariance, change in scores, and percent change in scores), using data from a randomized controlled trial of postoperative pain in patients following total joint arthroplasty (the Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study [MOBILE] trials).MethodsAnalysis of covariance (ANCOVA) was used to adjust for baseline measures and to provide an unbiased estimate of the mean group difference of the 1-year postoperative knee flexion scores in knee arthroplasty patients. Robustness tests were done by comparing ANCOVA with three comparative methods: the posttreatment scores, change in scores, and percentage change from baseline.ResultsAll four methods showed similar direction of effect; however, ANCOVA (−3.9; 95% confidence interval [CI]: −9.5, 1.6; P=0.15) and the posttreatment score (−4.3; 95% CI: −9.8, 1.2; P=0.12) method provided the highest precision of estimate compared with the change score (−3.0; 95% CI: −9.9, 3.8; P=0.38) and percent change (−0.019; 95% CI: −0.087, 0.050; P=0.58).ConclusionANCOVA, through both simulation and empirical studies, provides the best statistical estimation for analyzing continuous outcomes requiring covariate adjustment. Our empirical findings support the use of ANCOVA as an optimal method in both design and analysis of trials with a continuous primary outcome.

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Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial

Abstract: Gabapentin 600 mg po given preoperatively followed by 200 mg po every eight hours for two days has no effect on postoperative morphine consumption, pain scores, patient satisfaction, or length of hospital stay. This trial is registered at ClinicalTrials.gov NCT01307202.

Cited by 61 publications

References 26 publications

Research design considerations for chronic pain prevention clinical trials

Research design considerations for chronic pain prevention clinical trials

Gabapentin in procedure-specific postoperative pain management – preplanned subgroup analyses from a systematic review with meta-analyses and trial sequential analyses

Empirical comparison of four baseline covariate adjustment methods in analysis of continuous outcomes in randomized controlled trials

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