PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial

Trial acronym: PANSAID

Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy.

Objectives: 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.

Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.

Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients, and statisticians.

Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004 (two-sided) and a type 2 error rate of 0,10.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Hägi-Pedersen
• Collaborator: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• Scheduled for unilateral, primary Total Hip Arthroplasty (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.

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, 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.