A systematic review of pain outcomes reported by randomised trials of hip and knee arthroplasty

Koyuncu, S.; Friis, C. P.; Laigaard, Jens; Anhøj, Jacob; Mathiesen, Ole; Karlsen, Anders Peder Højer

doi:10.1111/anae.15118

Cited by 17 publications

(35 citation statements)

References 54 publications

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“…In line with several other trials on pain after total joint arthroplasty, 28 we chose morphine consumption as our primary outcome. The differences in the opioid use decided by the patient show the differences in pain relief achieved (that is, analgesic efficacy) between the intervention and placebo groups and can therefore be considered as a valid surrogate outcome mirroring patients’ total pain.…”

Section: Discussionmentioning

confidence: 99%

Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial

Gasbjerg

Hägi‐Pedersen

Lunn

et al. 2022

BMJ

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Objective To investigate the effects of one and two doses of intravenous dexamethasone in patients after total knee arthroplasty. Design Randomised, blinded, placebo controlled trial with follow-up at 90 days. Setting Five Danish hospitals, September 2018 to March 2020. Participants 485 adult participants undergoing total knee arthroplasty. Intervention A computer generated randomised sequence stratified for site was used to allocate participants to one of three groups: DX1 (dexamethasone (24 mg)+placebo); DX2 (dexamethasone (24 mg)+dexamethasone (24 mg)); or placebo (placebo+placebo). The intervention was given preoperatively and after 24 hours. Participants, investigators, and outcome assessors were blinded. All participants received paracetamol, ibuprofen, and local infiltration analgesia. Main outcome measures The primary outcome was total intravenous morphine consumption 0 to 48 hours postoperatively. Multiplicity adjusted threshold for statistical significance was P<0.017 and minimal important difference was 10 mg morphine. Secondary outcomes included postoperative pain. Results 485 participants were randomised: 161 to DX1, 162 to DX2, and 162 to placebo. Data from 472 participants (97.3%) were included in the primary outcome analysis. The median (interquartile range) morphine consumptions at 0-48 hours were: DX1 37.9 mg (20.7 to 56.7); DX2 35.0 mg (20.6 to 52.0); and placebo 43.0 mg (28.7 to 64.0). Hodges-Lehmann median differences between groups were: −2.7 mg (98.3% confidence interval −9.3 to 3.7), P=0.30 between DX1 and DX2; 7.8 mg (0.7 to 14.7), P=0.008 between DX1 and placebo; and 10.7 mg (4.0 to 17.3), P<0.001 between DX2 and placebo. Postoperative pain was reduced at 24 hours with one dose, and at 48 hours with two doses, of dexamethasone. Conclusion Two doses of dexamethasone reduced morphine consumption during 48 hours after total knee arthroplasty and reduced postoperative pain. Trial registration Clinicaltrials.gov NCT03506789 .

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Section: Discussionmentioning

confidence: 99%

Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial

Gasbjerg

Hägi‐Pedersen

Lunn

et al. 2022

BMJ

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“…34,35 Further, trials of acute postoperative pain are characterised by low attrition rates because of short follow-up periods. 24 Therefore, we recommend triallists to refrain from large sample size adjustments to minimise significance/MCID mismatch. 14,17 The clinical relevance of an intervention depends on the effect in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…20e22 The procedures are associated with substantial postoperative pain, and numerous RCTs have been published investigating different analgesic treatments. 23,24 In this systematic review, we aimed to investigate the reported MCIDs in RCTs on postoperative pain management after THA and TKA as markers for clinician-perceived MCIDs. Further, we investigated the adequacy in reporting of sample size calculations, the tendency to report significant but clinically irrelevant differences, and statistical considerations for pain score and opioid consumption outcomes.…”

mentioning

confidence: 99%

Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review

Laigaard

Pedersen

Rønsbo

et al. 2021

British Journal of Anaesthesia

196

104

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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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“…We have chosen patient‐reported pain score as our primary outcome because it is the most direct measure of patient‐experienced pain. Moreover, pain scores reflect both functional ability and quality of life 40 and are a frequently reported outcome 5 . We expect more trials to report pain scores as continuous data.…”

Section: Discussionmentioning

confidence: 99%

Perioperative prevention of persistent pain after total hip and knee arthroplasty—Protocol for two systematic reviews

Laigaard

Karlsen

Maagaard

et al. 2022

Acta Anaesthesiol Scand

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Background: Between 9% and 20% of patients experience moderate to severe persistent postoperative pain after total hip or knee arthroplasty. Severe immediate postoperative pain limits rehabilitation and is associated with the development of persistent postoperative pain. Therefore, perioperative analgesic and physiotherapeutic interventions are of interest to reduce persistent pain. In two systematic reviews with identical methodology, we aim to investigate the effects of (a) perioperative analgesic interventions and (b) physiotherapeutic interventions in reducing persistent pain after total hip and knee arthroplasty.Methods: We will include randomised and cluster-randomised controlled trials on perioperative analgesic and physiotherapeutic interventions for patients undergoing elective total hip or knee arthroplasty for osteoarthritis. After contact with the authors, trials without pain data 3-24 months postoperatively will be excluded.Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and reference lists will be searched for eligible trials. Two authors will independently screen, extract data and assess the risk of bias. The primary outcome is pain scores 3-24 months postoperatively. Meta-analyses will be performed for interventions with two or more trials. We will conduct trial sequential analyses and assign Grading of Recommendations, Assessment, Development and Evaluation (GRADE) ratings. Conclusion:No previous review on reduction of persistent postoperative pain has included non-pharmacological or invasive analgesic techniques. These two reviews with identical methodology will summarise the evidence of analgesic and physiotherapeutic perioperative interventions to prevent persistent pain.

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A systematic review of pain outcomes reported by randomised trials of hip and knee arthroplasty

Cited by 17 publications

References 54 publications

Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial

Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial

Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review

Perioperative prevention of persistent pain after total hip and knee arthroplasty—Protocol for two systematic reviews

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