Perioperative Multimodal Analgesia for Supratentorial Craniotomy

NCT07441421 | Not Yet Recruiting DMC

• 1 other identifier: 20260220
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Pain; Analgesia; Supratentorial Brain Tumor

Keywords

multimodal analgesia; postoperative acute pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Scalp nerve blocks plus placebo dexmedetomidine infusion

EXPERIMENTAL

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

Placebo scalp nerve blocks plus dexmedetomidine infusion

EXPERIMENTAL

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

Both active treatments

EXPERIMENTAL

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; Procedure: Scalp-Nerve Block

Double placebo

NO INTERVENTION

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.

Interventions

Dexmedetomidine DRUG

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.

Both active treatments; Placebo scalp nerve blocks plus dexmedetomidine infusion

Scalp-Nerve Block PROCEDURE

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.

Both active treatments; Scalp nerve blocks plus placebo dexmedetomidine infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yuming Peng, Dr

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Zeng, Dr

CONTACT

8610-59976658; fly800727@163.com

Muhan Li, Dr

CONTACT

8610-59976658; limuhan8816@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02