Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy

NCT06406829 | Not Yet Recruiting DMC

• 1 other identifier: 2024007
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Supratentorial Brain Tumor; Postoperative Pain; Analgesia

Keywords

multimodal analgesia; Postoperative acute pain

Outcome Measures

Primary Outcomes (1)

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

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

  48 hours postoperatively

Study Arms (4)

Local analgesic techniques + dexmedetomidine group

EXPERIMENTAL

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; Other: Local analgesic techniques

Local analgesic techniques and placebo dexmedetomidine group

EXPERIMENTAL

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; Other: Local analgesic techniques

Placebo local analgesic techniques and dexmedetomidine group

EXPERIMENTAL

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; Other: no Local analgesic techniques

Placebo local analgesic techniques and placebo dexmedetomidine group

PLACEBO COMPARATOR

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; Other: no Local analgesic techniques

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.

Also known as: DEX

Local analgesic techniques + dexmedetomidine group; Placebo local analgesic techniques and dexmedetomidine group

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

Also known as: NS

Local analgesic techniques and placebo dexmedetomidine group; Placebo local analgesic techniques and placebo dexmedetomidine group

Local analgesic techniques OTHER

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

Also known as: LAT

Local analgesic techniques + dexmedetomidine group; Local analgesic techniques and placebo dexmedetomidine group

no Local analgesic techniques OTHER

No Local analgesic techniques will be given.

Also known as: NLAT

Placebo local analgesic techniques and dexmedetomidine group; Placebo local analgesic techniques and placebo dexmedetomidine group

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
• 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; Saline Solution

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yuming Peng, Dr

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Peng, Dr

CONTACT

8610-59976658; florapym766@163.com

Min Zeng, Dr

CONTACT

15810617027; fly800727@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: May 6, 2024
• First Posted: May 9, 2024
• Study Start: February 9, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02