Randomized open-label phase II study comparing oxycodone-naloxone with oxycodone in early return of gastrointestinal...

Area of Science:

• Colorectal Surgery
• Enhanced Recovery Protocols
• Pharmacology

Background:

• Opioid-induced gut dysfunction is a concern in postoperative recovery.
• Combined oral modified-release oxycodone-naloxone is being investigated for its potential to mitigate this.
• Enhanced recovery after surgery (ERAS) protocols aim to optimize patient outcomes.

Purpose of the Study:

• To assess the feasibility of a randomized trial for oxycodone-naloxone in ERAS for laparoscopic colorectal resection.
• To evaluate recruitment, retention, and protocol adherence.
• To explore preliminary effects on gut function and opioid consumption.

Main Methods:

• A single-center, open-label, phase II feasibility study.
• Patients received either oxycodone-naloxone or oxycodone for analgesia.
• Primary endpoints: recruitment, retention, protocol compliance. Secondary endpoints: gut function metrics (food tolerance, nausea/vomiting, bowel movements).

Main Results:

• 62 patients were randomized with a 19% attrition rate; 50 completed the study with 100% follow-up.
• Protocol compliance exceeded 90%.
• The oxycodone-naloxone group showed a significantly shorter time to first bowel movement (P=0.031) and a trend towards reduced total opioid consumption, though return of gut function was similar between groups.

Conclusions:

• The study confirmed the feasibility of conducting a randomized trial of oxycodone-naloxone in this setting.
• Results suggest potential benefits in reducing time to bowel movement and opioid requirements.
• Further randomized controlled trials are warranted to confirm these findings.