NCT06406829

Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy

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

Supratentorial craniotomy is one of the most common neurosurgical procedures, with severe perioperative pain. Inadequate perioperative pain relief has been associated with increased blood pressure and intracranial pressure, favoring bleeding and cerebral cerebral hypoperfusion. The ideal analgesia for neurosurgery requires complete pain relief, eliminates the side effects of opioid drugs and no influence for neurological function. Previous studies have proposed a multimodal analgesic strategy, combining analgesics and local anaesthesia, it is expected to achieve the above benefits.

Detailed description

The trial has been designed to analyze the efficacy of local analgesic techniques and dexmedetomidine in the treatment of postoperative acute pain in craniotomy. This randomized clinical trial aims to enroll 2000 patients, which will be randomized to one of 4 groups.

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.
DRUG	Normal saline	In the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group
OTHER	Local analgesic techniques	As for scalp nerve block, each nerve will be blocked separately with 1-2 mL of 0.67 % liposomal bupivacaine
OTHER	no Local analgesic techniques	No Local analgesic techniques will be given.

Timeline

• Start date: 2026-02-09
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-05-09
• Last updated: 2026-02-11