Effect of Combinations of Well-known Analgesics: Combining Basic Painkillers Paracetamol and Ibuprofen, and the Steroidal Hormone Dexamethasone, to Reduce Need of Morphine in Patients Undergoing Hip Replacement Surgery.

Phase 1

• Conditions: Acute postoperative pain after hip arthroplasty; MedDRA version: 20.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863; MedDRA version: 20.0Level: PTClassification code 10020096Term: Hip arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-002844-25-DK
• Lead Sponsor: Daniel Hägi-Pedersen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-26
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1060

Inclusion Criteria

•Scheduled for elective, unilateral, primary total hip arthroplasty
•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 424
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 636

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified