Perioperative Multimodal Analgesia for Supratentorial Craniotomy

Capital Medical University

Status: Not yet enrolling

Conditions: Postoperative Pain; Analgesia; Supratentorial Brain Tumor

Treatments: Procedure: Scalp-Nerve Block; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07441421

20260220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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2,000 participants in 4 patient groups

Scalp nerve blocks plus placebo dexmedetomidine infusion

Experimental group

Description:

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.

Treatment:

Procedure: Scalp-Nerve Block

Placebo scalp nerve blocks plus dexmedetomidine infusion

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Both active treatments

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Procedure: Scalp-Nerve Block

Double placebo

No Intervention group

Description:

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.