Status:
COMPLETED
Effect of Combinations of Paracetamol, Ibuprofen, and Dexamethasone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty
Lead Sponsor:
Naestved Hospital
Conditions:
Pain, Acute
Hip Arthropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
1060 Patients enrolled
Trial Details
Trial ID
NCT04123873
Start Date
March 5 2020
End Date
February 15 2023
Last Update
June 1 2023
Active Locations (7)
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1
Næstved-Slagelse-Ringsted Hospitals
Næstved, Danmark, Denmark, 4700
2
Bispebjerg Hospital
Copenhagen, Denmark, 2400
3
Gentofte Hospital
Hellerup, Denmark, 2900
4
Hillerød Hospital
Hillerød, Denmark, 3400