NCT07441421

Perioperative Multimodal Analgesia for Supratentorial Craniotomy

Perioperative Multimodal Analgesia for Supratentorial Craniotomy：Protocol for a 2× 2 Factorial Randomized Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial aims to evaluate the effectiveness of scalp nerve blocks and dexmedetomidine in reducing opioid use and preventing postoperative delirium in patients undergoing supratentorial brain tumor surgery. A total of 2000 patients will be randomly assigned to one of four groups, receiving either active treatments, placebos, or their combinations. The main outcome measured will be the amount of opioid pain medication needed after surgery.

Detailed description

This single-center, double-blind, placebo-controlled trial employs a 2x2 factorial design to evaluate two non-opioid interventions: preoperative scalp nerve blocks and perioperative dexmedetomidine infusion. Eligible patients scheduled for elective supratentorial tumor resection will be randomized into four groups: 1) scalp nerve blocks plus placebo dexmedetomidine infusion; 2) placebo scalp nerve blocks plus dexmedetomidine infusion; 3)both active treatments; and 4) double placebo. The primary outcomes are cumulative sufentanil consumption via patient-controlled analgesia during the first 48 postoperative hours. Secondary outcomes include the incidence of postoperative delirium within 3 days assessed using CAM-ICU/3D-CAM, pain scores, total perioperative opioid use, quality of recovery, and persistent incisional pain. Results will provide evidence for optimizing analgesia while minimizing opioid-related complications in neurosurgical patients.

Conditions

• Postoperative Pain
• Analgesia
• Supratentorial Brain Tumor

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively and 0.05 μg/kg/h for 48 hours after surgery.
PROCEDURE	Scalp-Nerve Block	The 10ml 1.33% liposomal bupivacaine will be diluted into a 20ml syringe. As for scalp nerve block, each nerve will be blocked separately with 1-2 mL 0.67% liposomal bupivacaine.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-03-02
• Last updated: 2026-03-02