Perioperative Multimodal Analgesia for Supratentorial Craniotomy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Analgesia; Supratentorial Brain Tumor
• Intervention / Treatment: Drug: Dexmedetomidine; Procedure: Scalp-Nerve Block

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.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Zeng, Dr; Phone Number: 8610-59976658; Email: fly800727@163.com
• Study Contact Backup: Name: Muhan Li, Dr; Phone Number: 8610-59976658; Email: limuhan8816@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged from 18 to 65 years
• American Society of Anesthesiologists physical status I to III
• Scheduled to undergo elective supratentorial tumor resection

Exclusion Criteria:

• Incision-area skin infection
• A history of previous craniotomy
• Allergy to study medications
• A history of preoperative change in consciousness or cognitive function
• Inability to communicate,
• Preoperative pain in the surgical region
• Severe hepatic or renal dysfunction
• Severe bradycardia (heart rate<40 beats/min)
• Sick sinus syndrome or second- to-third degree atrioventricular block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scalp nerve blocks plus placebo dexmedetomidine infusion; Patients in this group will receive a scalp nerve block with liposomal bupivacaine before surgery. They will receive a continuous intravenous infusion of normal saline (placebo) at the same rate and via identical infusion pumps as used for the dexmedetomidine infusion in the active comparator group.	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.
Experimental: Placebo scalp nerve blocks plus dexmedetomidine infusion; Patients in this group will receive a sham block (no local anesthetic or saline injected). They will receive a continuous intravenous infusion of dexmedetomidine, starting from anesthesia induction until dural closure at a rate of 0.4 μg/kg/h, followed by a maintenance dose of 0.05 μg/kg/h for 48 hours postoperatively.	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.
Experimental: Both active treatments; Patients in this group will receive scalp nerve block before surgery with liposomal bupivacaine. They will also receive a continuous intravenous infusion of dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from anesthesia induction until dural closure, followed by a maintenance dose of 0.05 μg/kg/h for 48 hours postoperatively.	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.
No Intervention: Double placebo; Patients in this group will receive a sham scalp nerve block (no injection). The patients in this group will not receive scalp nerve block. From the start of surgery until 48 hours postoperatively, they will receive a continuous intravenous infusion of normal saline (placebo) at the same rate and via identical infusion pumps as used for the dexmedetomidine infusion in the active comparator group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively	Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively	48 hours postoperatively

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Yuming Peng, Dr, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: multimodal analgesia; postoperative acute pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Agnosia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: 20260220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No