Dataset Information

Paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty: protocol for the randomised, placebo-controlled, parallel 4-group, blinded, multicentre RECIPE trial.

ABSTRACT:

Introduction

Multimodal analgesia with paracetamol, non-steroidal anti-inflammatory drug and glucocorticoid is recommended for hip arthroplasty, but with uncertain effects of the different combinations. We aim to investigate benefit and harm of different combinations of paracetamol, ibuprofen and dexamethasone following total hip arthroplasty.

Methods and analysis

RECIPE is a randomised, placebo-controlled, parallel 4-group, blinded trial with 90-day and 1-year follow-up performed at nine Danish hospitals. Interventions are initiated preoperatively and continued for 24 hours postoperatively. Eligible participants undergoing total hip arthroplasty are randomised to:group A: oral paracetamol 1000 mg × 4+oral ibuprofen 400 mg × 4+intravenous placebo; group B: oral paracetamol 1000 mg × 4+intravenous dexamethasone 24 mg+oral placebo; group C: oral ibuprofen 400 mg × 4+intravenous dexamethasone 24 mg+oral placebo; group D: oral paracetamol 1000 mg × 4+oral ibuprofen 400 mg × 4+intravenous dexamethasone 24 mg.Primary outcome is cumulative opioid consumption at 0-24 hours. Secondary outcomes are pain at rest, during mobilisation and during a 5 m walk and adverse events. Follow-up includes serious adverse events and patient reported outcome measures at 90 days and 1 year. A total of 1060 participants are needed to demonstrate a difference of 8 mg in 24-hour morphine consumption assuming an SD of 24.5 mg, a risk of type I errors of 0.0083 and a risk of type 2 errors of 0.2. Primary analysis will be a modified intention-to-treat analysis.With this trial we aim to verify recommendations for pain treatment after total hip arthroplasty, and investigate the role of dexamethasone as an analgesic adjuvant to paracetamol and ibuprofen.

Ethics and dissemination

This trial is approved by the Region Zealand Committee on Health Research Ethics (SJ-799). Plans for dissemination include publication in peer-reviewed journals and presentation at scientific meetings.

Trial registration number

NCT04123873.

SUBMITTER: Steiness J

PROVIDER: S-EPMC9438203 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

Paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty: protocol for the randomised, placebo-controlled, parallel 4-group, blinded, multicentre RECIPE trial.

Steiness Joakim J Hägi-Pedersen Daniel D Lunn Troels Haxholdt TH Lindberg-Larsen Martin M Graungaard Ben Kristian BK Lundstrom Lars Hyldborg LH Lindholm Peter P Brorson Stig S Bieder Manuel Josef MJ Beck Torben T Skettrup Michael M von Cappeln Adam Gregers AG Thybo Kasper Højgaard KH Gasbjerg Kasper Smidt KS Overgaard Søren S Jakobsen Janus Christian JC Mathiesen Ole O

BMJ open 20220901 9

<h4>Introduction</h4>Multimodal analgesia with paracetamol, non-steroidal anti-inflammatory drug and glucocorticoid is recommended for hip arthroplasty, but with uncertain effects of the different combinations. We aim to investigate benefit and harm of different combinations of paracetamol, ibuprofen and dexamethasone following total hip arthroplasty.<h4>Methods and analysis</h4>RECIPE is a randomised, placebo-controlled, parallel 4-group, blinded trial with 90-day and 1-year follow-up performed ...[more]

PMID: 36190737

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Project description:IntroductionHip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain, and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appears to improve multiple outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary aim of this trial is to investigate whether THA followed by standard care is superior to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT for improving hip pain and function in patients with severe hip OA.Methods and analysisThis is a protocol for a multicentre, parallel-group, assessor-blinded, randomised controlled superiority trial conducted at four hospitals across three healthcare regions in Denmark. 120 patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA followed by standard care, or 12 weeks of PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score, from baseline to 6 months after initiating the treatment. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40 m fast-paced walk test, 30 s chair stand test and occurrence of serious adverse events. Patients declining participation in the trial will be invited into a prospective observational cohort study.Ethics and disseminationThe trial has been approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20180158). All results will be presented in peer-reviewed scientific journals and international conferences.Trial registration numberClinicalTrials.gov (NCT04070027).

Project description:BackgroundPrevious studies have shown that dexamethasone has a positive effect on postoperative pain control, opioid consumption, nausea, and vomiting and length of hospital stay after arthroplasty surgery.Purpose/hypothesisThe purpose of this study was to assess whether adding perioperative dexamethasone to our current pain regimen after hip arthroscopy is more effective than a placebo. It was hypothesized that dexamethasone would reduce postoperative pain, reduce opioid consumption, improve subjective pain and nausea scores, and reduce the number of vomiting events.Study designRandomized controlled trial; Level of evidence, 1.MethodsA total of 50 patients requiring unilateral elective hip arthroscopy were randomized to receive intravenous dexamethasone immediately before induction of anesthesia and at 8 am on the first postoperative day (2 ×12 mg) or a placebo (sodium chloride 0.9%). The patient, the surgeons, the treating anesthesiologist, and the involved nursing and physical therapy personnel were blinded to group assignment. The primary outcome was postoperative pain, and secondary outcomes were opioid consumption and nausea scores-assessed using a translated revised version of the American Pain Society Patient Outcome Questionnaire 6 hours postoperatively and on days 1 and 2-and vomiting events. A clinical follow-up was performed 12 weeks postoperatively to assess adverse events.ResultsThe mean age at inclusion was 29 years in both groups. Postoperative pain levels did not differ significantly in most instances. Opioid requirements during the hospitalization in the dexamethasone group were significantly lower than those in the placebo group (31.96 ± 20.56 mg vs 51.43 ± 38 mg; P = .014). Significantly fewer vomiting events were noted in the dexamethasone group (0.15 ± 0.59 vs 0.65 ± 0.91; P = .034). Descriptive data and surgical parameters did not differ significantly.ConclusionPerioperative intravenous dexamethasone significantly reduced postoperative opioid consumption by 40% without compromising pain level and safety, as no corticosteroid-related side effects were observed. Dexamethasone may be a valuable adjuvant to a multimodal systemic pain regimen after hip arthroscopy.RegistrationNCT04610398 (ClinicalTrials.gov identifier).

Project description:ImportanceMultimodal postoperative analgesia is widely used but lacks evidence of benefit.ObjectiveInvestigate beneficial and harmful effects of 4 nonopioid analgesics regimens.Design, setting, and participantsRandomized, blinded, placebo-controlled, 4-group trial in 6 Danish hospitals with 90-day follow-up that included 556 patients undergoing total hip arthroplasty (THA) from December 2015 to October 2017. Final date of follow-up was January 1, 2018.InterventionsParticipants were randomized to receive paracetamol (acetaminophen) 1000 mg plus ibuprofen 400 mg (n = 136; PCM + IBU), paracetamol 1000 mg plus matched placebo (n = 142; PCM), ibuprofen 400 mg plus matched placebo (n = 141; IBU), or half-strength paracetamol 500 mg plus ibuprofen 200 mg (n = 140; HS-PCM + IBU) orally every 6 hours for 24 hours postoperatively, starting 1 hour before surgery.Main outcomes and measuresTwo co-primary outcomes: 24-hour morphine consumption using patient-controlled analgesia in pairwise comparisons between the 4 groups (multiplicity-adjusted thresholds for statistical significance, P < .0042; minimal clinically important difference, 10 mg), and proportion of patients with 1 or more serious adverse events (SAEs) within 90 days (multiplicity-adjusted thresholds for statistical significance, P < .025).ResultsAmong 559 randomized participants (mean age, 67 years; 277 [50%] women), 556 (99.5%) completed the trial and were included in the analysis. Median 24-hour morphine consumption was 20 mg (99.6% CI, 0-148) in the PCM + IBU group, 36 mg (99.6% CI, 0-166) for PCM alone, 26 mg (99.6% CI, 2-139) for IBU alone, and 28 mg (99.6% CI, 2-145) for HS-PCM + IBU. The median difference in morphine consumption between the PCM + IBU group vs PCM alone was 16 mg (99.6% CI, 6.5 to 24; P < .001); for the PCM-alone group vs HS-PCM + IBU, 8 mg (99.6% CI, -1 to 14; P = .001); and for the PCM + IBU group vs IBU alone, 6 mg (99.6% CI, -2 to 16; P = .002). The difference in morphine consumption was not statistically significant for the PCM + IBU group vs HS-PCM + IBU (8 mg [99.6% CI, -2 to 16]; P = .005) or for the PCM-alone group vs IBU alone (10 mg [99.6% CI, -2 to 16]; P = .004) after adjustment for multiple comparisons and 2 co-primary outcomes. There was no significant difference between the IBU-alone group vs HS-PCM + IBU (2 mg [99.6% CI, -10 to 7]; P = .81). The proportion of patients with SAEs in groups receiving IBU was 15%, and in the PCM-alone group, was 11%. The relative risk of SAE was 1.44 (97.5% CI, 0.79 to 2.64; P = .18).Conclusions and relevanceAmong patients undergoing THA, paracetamol plus ibuprofen significantly reduced morphine consumption compared with paracetamol alone in the first 24 hours after surgery; there was no statistically significant increase in SAEs in the pooled groups receiving ibuprofen alone vs with paracetamol alone. However, the combination did not result in a clinically important improvement over ibuprofen alone, suggesting that ibuprofen alone may be a reasonable option for early postoperative oral analgesia.Trial registrationClinicalTrials.gov Identifier: NCT02571361.

Project description:ObjectiveThe primary objective of the trial was to assess the clinical effectiveness of medial unicompartmental knee arthroplasty versus total knee arthroplasty in patients with isolated medial osteoarthritis of the knee.DesignProspective, randomised, 2 years, assessor-blind, multicentre, superiority trial.SettingThe patients were enrolled between December 2015 and May 2018 from the outpatient clinics of three public high-volume arthroplasty hospitals (Finland).ParticipantsWe recruited 143 patients with symptomatic-isolated medial osteoarthritis of the knee needing an arthroplasty procedure. All the patients were suitable for both unicompartmental and total knee arthroplasties. Population was selected as the end-stage-isolated medial osteoarthritis.InterventionsAll patients, randomized 1:1, received a medial unicompartmental arthroplasty or a total knee arthroplasty through a similar midline skin incision. Patients were blinded to the type of arthroplasty for the whole 2 years of follow-up.Main outcome measuresPrimary outcome measure was between-group differences in the Oxford Knee Score (OKS) and secondary outcome Knee injury and Osteoarthritis Score (KOOS) at 2 years postoperatively. The changes within and between the groups were analysed with analysis of variance for repeated measurements.ResultsThe primary outcome was comparable for medial unicompartmental arthroplasty and total knee arthroplasty at 2 years. The mean difference in the OKS between the groups was 1.6 points (95% CI -0.7 to 3.9). In the KOOS subscales, the mean difference between the groups was 0.1 points (95% CI -4.8 to 5.0) for pain, 7.8 points (95% CI 1.5 to 14.0) for symptoms, 4.3 points (95% CI -0.6 to 9.2) for function in daily living, 4.3 points (95% CI -3.0 to 11.6) for function in sports, and 2.1 points (95% CI -4.8 to 9.1) for knee-related quality of life.ConclusionsThe recovery after unicompartmental knee arthroplasty was faster compared with total knee arthroplasty, but unicompartmental arthroplasty did not provide a better patient-reported outcome at 2 years.Trial registration numberNCT02481427.

Dataset Information

Paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty: protocol for the randomised, placebo-controlled, parallel 4-group, blinded, multicentre RECIPE trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty: protocol for the randomised, placebo-controlled, parallel 4-group, blinded, multicentre RECIPE trial.

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