PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial

Area of Science:

• Orthopedics
• Pain Management
• Pharmacology

Background:

• Effective postoperative pain management is crucial for surgical patient rehabilitation.
• No definitive 'gold standard' exists for pain relief after total hip arthroplasty (THA).
• Current practice often uses nonopioid medication combinations without strong evidence for enhanced efficacy over monotherapy.

Purpose of the Study:

• To investigate the analgesic effects and safety of paracetamol and ibuprofen, alone and in combination, at different dosages following THA.
• To compare the efficacy of various nonopioid analgesic regimens in managing postoperative pain.
• To evaluate the safety profile of combined paracetamol and ibuprofen therapy post-THA.

Main Methods:

• A placebo-controlled, four-group, multicentre trial (PANSAID) involving patients undergoing primary THA.
• Randomized allocation to four groups: (A) paracetamol + ibuprofen, (B) paracetamol + placebo, (C) placebo + ibuprofen, (D) lower-dose paracetamol + lower-dose ibuprofen.
• Co-primary outcomes included 24-h morphine consumption and incidence of serious adverse events within 90 days; secondary outcomes assessed pain scores and adverse events within 24 hours.

Main Results:

• The study is ongoing; recruitment began in December 2015 and is expected to conclude in September 2017.
• Data analysis and manuscript submission are scheduled for late 2017.
• Full results regarding morphine consumption and adverse events are pending.

Conclusions:

• The study aims to provide evidence-based recommendations for nonopioid pain management after THA.
• Findings will inform clinical practice regarding the optimal use of paracetamol and ibuprofen for postoperative pain.
• The research will contribute to understanding the efficacy and safety of analgesic combinations versus monotherapy.