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NCT Number: NCT07441421

Perioperative Multimodal Analgesia for Supratentorial Craniotomy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively

    Time frame: 48 hours postoperatively

    Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively

Study contacts

Contact information is provided by the study sponsor or research team.

Min Zeng, Dr

CONTACT

[email protected]

8610-59976658

Muhan Li, Dr

CONTACT

[email protected]

8610-59976658

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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