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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04123873
Other study ID # SM1-JOAST-2019
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 5, 2020
Est. completion date February 15, 2023

Study information

Verified date May 2023
Source Naestved Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multimodal pain management is essential for recovery after surgery, aiming to target different pain mechanisms to minimize opioid usage and opioid-related adverse effects. Evidence for benefits and harms of various non-opioid analgesic combinations is, however, nearly non-existing, and large-scale trials are urgently needed. Recently, the investigators have demonstrated that combining paracetamol and ibuprofen is superior to each single drug when assessing pain after hip replacement. Further improvement is needed, investigating additional non-opioid analgesics to this combination. Glucocorticoids have anti-emetic and analgesic properties, but evidence for analgesic efficacy in combination with paracetamol and ibuprofen is lacking. The RECIPE trial is an investigator-initiated randomized, placebo-controlled, parallel, 4-group, blinded multicentre trial with 90-day follow-up investigating benefits and harms of different combinations of paracetamol, ibuprofen, and dexamethasone for patients undergoing total hip arthroplasty. The primary outcome is total use of IV morphine 0-24 hours postoperatively. Secondary outcomes are pain (upon mobilisation, at rest, and during 5 m walk), and adverse events. Exploratory outcomes include quality of sleep, opioid-related adverse effects, serious adverse events (< 90 days), and patient reported disability score and quality of life (at 90 days). Based on sample-size calculations, 1060 patients are needed to detect a minimal clinically important difference in 24-hour morphine consumption of 8 mg, using a familywise type 1 error rate of 0.05 and a type 2 error rate of 0.2. The primary analyses will be based on the intention to treat population. More than six Danish university- and regional hospitals will participate in the trial. With this trial the investigators expect to lay the foundation for the best postoperative multimodal analgesic regimen for both total hip arthroplasty and possibly other surgeries, thereby facilitating recovery for millions of future surgical patients worldwide.


Recruitment information / eligibility

Status Completed
Enrollment 1060
Est. completion date February 15, 2023
Est. primary completion date November 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Scheduled for elective, unilateral, primary THA - Age = 18 - ASA 1-3 - BMI > 18 and < 40 - Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age - Give written informed consent to participate in the trial after having fully understood the contents of the protocol and restrictions Exclusion Criteria: - Patients who cannot cooperate with the trial - Concomitant participation in another trial involving medication - Patients who cannot understand or speak Danish - Patients with allergy to medication used in the trial - Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids. - Patients with daily use of systemic glucocorticoids (within 3 months before the trial) - Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (< 100 x 109/l); or against treatment with glucocorticoids - Dysregulated diabetes (investigator's judgement) - Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement

Study Design


Intervention

Drug:
Paracetamol
1g x 4 p.o.
Ibuprofen
400mg x 4 p.o.
Dexamethasone
24mg IV x 1 after induction om anaesthesia
Placebo oral capsules
p.o. x 4
Placebo IV
IV x 1

Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen
Denmark Gentofte Hospital Hellerup
Denmark Hillerød Hospital Hillerød
Denmark Køge Hospital Køge
Denmark Næstved-Slagelse-Ringsted Hospitals Næstved Danmark
Denmark Odense University Hospital (OUH) Odense
Denmark Svendborg Hospital Svendborg

Sponsors (1)

Lead Sponsor Collaborator
Naestved Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Serious adverse events within one year SAEs, including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines) except 'prolongation of hospitalisation' that has been modified to 'prolongation of hospitalization with =4 days' Within 90 days
Other Pain scores during mobilisation 6h Pain scores (visual analogue scale (VAS 0-100 mm; no pain = 0; worst imaginable pain = 100)) with active 30 degrees flexion of the hip 6 hours after end of surgery
Other Pain scores at rest 6h Pain scores at rest (VAS 0-100 mm; no pain = 0; worst imaginable pain = 100) 6 hours after end of surgery
Other Prevalence of nausea Prevalence of nausea, 6 and 24 hours after end of surgery 6 and 24 hours after end of surgery
Other Number of vomiting episodes The number of productive vomiting events (volume estimated over 10 ml) is recorded corresponding to the period 0-24 hours 0-24 after end of surgery. Reported by interview 24 hours after end of surgery
Other Consumption of ondansetron and dehydrobenzperidole Consumption of ondansetron and dehydrobenzperidole in mg 0-24 hours after end of surgery
Other Incidence of dizziness during 5 meter walk Incidence of dizziness during 5 meter walk 24 hours after surgery 24 hours after end of surgery
Other Blood loss Blood loss in ml during the surgical procedure Intraoperatively
Other Quality of sleep Quality of sleep (VAS 0-100 mm; worst possible sleep = 0; best possible sleep = 100) Worst possible sleep = 0; best possible sleep = 100 24 hours after end of surgery
Other Days alive and outside hospital within 90 days after surgery Days alive and outside hospital within 90 days after surgery Within 90 days after surgery
Other Oxford Hip Score at 90 days 5-point Lipert-scale (no, mild, moderate, severe and extreme) At 90 days after surgery
Other Quality of life (EQ-5D-5L) at 90 days EuroQol five-dimensions 5 point Lipert scale (EQ-5D-5L) At 90 days after surgery
Other Opioid use at 90 days Consumption of opioids within 90 days after surgery Within 90 days after surgery
Other Serious adverse events within 1 year Proportion of participants with one or more serious adverse events, including death, within one year after surgery, according to ICH-GCP guidelines[24] (except for 'prolongation of hospitalization' that has been modified to 'prolongation of hospitalization with =4 days') Within one year after surgery
Other Oxford Hip Score at one year 5-point Lipert-scale (no, mild, moderate, severe and extreme) One year after surgery
Other Quality of life (EQ-5D-5L) at one year EuroQol five-dimensions 5 point Lipert scale (EQ-5D-5L) One year after surgery
Other Opioid use at one year Consumption of opioids within one year after surgery Within one year after surgery
Primary Cumulative opioid consumption in the first 24 hours after surgery Cumulative opioid consumption in units of intravenous morphine equivalents in the first 24 postoperative hours. This includes opioids administered as (a) patient-controlled analgesia (PCA); (b) supplemental opioid administered at the post-anaesthesia care unit the first hour after end of surgery (general anaesthesia) or the first hour after ceasing of spinal anaesthesia; and (c) any supplemental opioid given at the ward 0-24 hours after end of surgery
Secondary Pain scores during mobilisation 24h Pain scores (visual analogue scale (VAS 0-100 mm; no pain = 0; worst imaginable pain = 100)) with active 30 degrees flexion of the hip 24 hours after end of surgery
Secondary Pain scores at rest 24h Pain scores at rest (VAS 0-100 mm; no pain = 0; worst imaginable pain = 100) 24 hours after end of surgery
Secondary Maximum level of pain Maximum level of pain (VAS 0-100 mm No pain = 0; worst imaginable pain = 100) during walk of 5 meters 24 hours after end of surgery
Secondary Adverse events in the intervention period Proportion of patients with one or more AEs in the intervention period From end of surgery + 24 hours
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