Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy

February 8, 2026 updated by: Yuming Peng, Beijing Tiantan Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • Severe hepatic or renal dysfunction
  • Severe bradycardia (heart rate<40 beats/min)
  • Sick sinus syndrome or second- to-third degree atrioventricular block

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo local analgesic techniques and dexmedetomidine group
The patients in this group will not receive scalp nerve block. The patients will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery.
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.
Other Names:
  • DEX
Other: no Local analgesic techniques
No Local analgesic techniques will be given.
Other Names:
  • NLAT
Placebo Comparator: Placebo local analgesic techniques and placebo dexmedetomidine group
The patients in this group will not receive scalp nerve block before surgery . For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine group during surgery and for 48 hours after surgery.
Drug: Normal saline
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
Other: no Local analgesic techniques
No Local analgesic techniques will be given.
Other Names:
  • NLAT
Experimental: Local analgesic techniques + dexmedetomidine group
The patients in this group will be received scalp nerve block before surgery with 0.67 % liposomal bupivacaine. The patients also will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery.
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.
Other Names:
  • DEX
Other: Local analgesic techniques
As for scalp nerve block, each nerve will be blocked separately with 1-2 mL of 0.67 % liposomal bupivacaine
Other Names:
  • LAT
Experimental: Local analgesic techniques and placebo dexmedetomidine group
The patients in this group will be received scalp nerve block before surgery with 0.67 % liposomal bupivacaine. For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine during surgery and for 48 hours after surgery.
Drug: Normal saline
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
Other: Local analgesic techniques
As for scalp nerve block, each nerve will be blocked separately with 1-2 mL of 0.67 % liposomal bupivacaine
Other Names:
  • LAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 9, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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