PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial (PANSAID)
Pain, Postoperative
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Acetaminophen, Ibuprofen, Arthroplasty, Replacement, Hip
Eligibility 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.
Sites / Locations
- Gildhøj Privathospital
- Holbæk Hospital
- Køge Hospital
- Nykøbing Falster Hospital
- Næstved Hospital
- Odense University Hospital (OUH)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Treatment A:
Treatment B:
Treatment C:
Treatment D:
Paracetamol 1g + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
Paracetamol 1g + placebo orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
Placebo + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
Paracetamol 0,5 g + ibuprofen 200 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.