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NCT Number: NCT06406829

Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy

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.

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Key information

Conditions

Postoperative Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Supratentorial Brain Tumor

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

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
  • 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.

Other names: DEX

normal saline

Drug

In the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group

Other names: NS

Local analgesic techniques

Other

As for scalp nerve block, each nerve will be blocked separately with 1-2 mL of 0.67 % liposomal bupivacaine

Other names: LAT

no Local analgesic techniques

Other

No Local analgesic techniques will be given.

Other names: NLAT

Primary outcomes

  1. Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively.

    Time frame: 48 hours postoperatively

    Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively.

Study contacts

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

Min Zeng, Dr

CONTACT

[email protected]

15810617027

Yuming Peng, Dr

CONTACT

[email protected]

8610-59976658

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 9, 2024
Registry last updated
Feb 11, 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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