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PANSAID can serve to
understand the benefits and harms of non-opioid multimodal analgesic procedures for post-surgical pain
relief.
Effective postoperative pain management is crucial for the rehabilitation
of the surgical patient. No ‘gold standard’ exists after total hip arthroplasty
(THA) and combinations of various nonopioid medications are employed with
virtually no evidence for further analgesic efficacy as compared to
monotherapy. The analgesic effects and safety of paracetamol and ibuprofen
alone and in combination in different dosages after THA have been explored in
this study.
A placebo-controlled, parallel four-group, multicentre
trial with centralised computer-generated allocation sequence and allocation
concealment along with varying block size and stratification by site is called
PANSAID. Blinding of assessor, investigator, caregivers, patients and
statisticians. The patients are stratified into four groups: (A) paracetamol
1 g × 4 and ibuprofen 400 mg × 4, (B) paracetamol 1 g × 4 and
placebo, (C) placebo and ibuprofen 400 mg × 4 and (D) paracetamol 0.5 g × 4
and ibuprofen 200 mg. Within 90 days after surgery, 24-h consumption of
morphine and number of patients with one or more serious adverse events were
depicted as the two co-primary outcomes. Pain scores during mobilisation and at
rest at 6 and 24 h postoperatively, and number of patients with one or
more adverse events within 24 h postoperatively were depicted as the
secondary outcomes. As per the inclusion criteria, the patients scheduled for
unilateral, primary THA; age above 18 years; ASA status 1–3; BMI >18
and <40 kg/m2; women must not be pregnant; and provision of informed
consent were considered. The exclusion criteria comprised of patients who
cannot cooperate with the trial; participation in another trial; patients who
cannot understand/speak Danish; daily use of strong opioids; allergy against
trial medication; contraindications against ibuprofen; alcohol and/or drug
abuse. Five hundred and fifty-six patients are required to reveal a difference
of 10 mg morphine i.v. the first 24 h postoperatively with a standard
deviation of 20 mg and a family wise type 1 error rate of 0.025
(two-sided) and a type 2 error rate of 0.10 for the six possible comparisons of
the four intervention groups.
This trial is expected to cease in September 2017. This trial was commenced in December 2015. The data estimation will be from September 2017 to October 2017 and manuscript submission ultimo 2017.
Biomed central Trials
PANSAID – PAracetamol and NSAID in combination: study protocol for a randomised trial
Kasper Højgaard Thybo et al.
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