Analgesic efficacy and safety of the combination of paracetamol and non-steroidal antiinflammatory drugs after elevtive hip surgery

Phase 1

Conditions: Pain after total hip replacement surgery
MedDRA version: 19.1Level: LLTClassification code 10044088Term: Total hip replacementSystem Organ Class: 100000004865
MedDRA version: 19.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-002239-16-DK

Lead Sponsor: æstved Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 556

Inclusion Criteria

•Scheduled for unilateral, primary THA
•Age > 18
•ASA 1-3.
•BMI > 18 and < 40
•Women in the fertile age must have negative urine HCG pregnancy test
•Patients who gave their written informed consent to participating 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 156
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

•Patients who cannot cooperate with the trial.
•Concomitant participation in another trial
•Patients who cannot understand or speak Danish.
•Daily use of strong opioids (tramadol and codein are accepted)
•Patients with allergy to the medicines used in the trial.
•Contraindications against NSAID or paracetamol, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L)
•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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA;Secondary Objective: Not applicable;Primary end point(s): •Total need for morphine the first 24 hours postoperatively administered as BOTH patient controlled analgesia (PCA) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively<br>•Serious adverse events, including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines) except prolongation of hospitalisation”<br>;Timepoint(s) of evaluation of this end point: Morphine consumption at 24 hours post surgery<br>Number of patients with one or more SAE's at 90 days post surgery

Secondary Outcome Measures