Non-opioid versus Opioid Peri-operative Analgesia In Neurosurgery (NOPAIN): Study protocol for a multi-centric...

Area of Science:

• Neurosurgery
• Anesthesiology
• Pain Management
• Pharmacology

Background:

• Post-operative pain is a significant issue for neurosurgery patients, often inadequately managed by intra-operative opioids.
• Opioid side effects pose particular risks in neurosurgical patients, necessitating alternative analgesia.
• Existing research comparing opioid and non-opioid analgesics in this population is limited and inconclusive.

Purpose of the Study:

• To compare the efficacy of dexmedetomidine versus fentanyl for intra-operative and post-operative pain control in patients undergoing brain tumor surgery.
• To evaluate secondary outcomes including adverse events, quality of recovery, sleep, patient satisfaction, and long-term pain and quality of life.
• To provide evidence for adopting non-opioid analgesics in neurosurgical pain management.

Main Methods:

• A multi-center, randomized controlled trial comparing fentanyl (intervention) with dexmedetomidine (comparator) in patients undergoing supra-tentorial brain tumor surgery.
• Primary outcomes include intra-operative rescue opioid requirements and post-operative pain scores.
• Ethics committee approval obtained; trial registered with Clinical Trial Registry-India.

Main Results:

• Recruitment for the multi-center trial commenced in October 2022 and is expected to conclude by March 2024.
• Data collection and analysis are ongoing as per the study protocol (version 2, dated 29/01/2022).

Conclusions:

• The study anticipates demonstrating dexmedetomidine's effectiveness as a non-opioid analgesic in the neurosurgical population.
• Findings are expected to guide clinical practice towards safer and more effective pain management strategies post-neurosurgery.