Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain; Analgesia; Supratentorial Brain Tumor
• Interventions: Drug: Dexmedetomidine; Drug: Normal saline; Other: Local analgesic techniques; Other: no Local analgesic techniques

• Registration Number: NCT06406829
• Lead Sponsor: Beijing Tiantan Hospital

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.

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 Timeline

• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-13
• Study Start: 2025-03-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Local analgesic techniques + dexmedetomidine group	Dexmedetomidine	The patients in this group will be received scalp nerve block before surgery with 0.5% ropivacaine. 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.
Local analgesic techniques + dexmedetomidine group	Local analgesic techniques	The patients in this group will be received scalp nerve block before surgery with 0.5% ropivacaine. 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.
Local analgesic techniques and placebo dexmedetomidine group	Normal saline	The patients in this group will be received scalp nerve block before surgery with 0.5% ropivacaine. For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine during surgery and for 48 hours after surgery.
Local analgesic techniques and placebo dexmedetomidine group	Local analgesic techniques	The patients in this group will be received scalp nerve block before surgery with 0.5% ropivacaine. For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine during surgery and for 48 hours after surgery.
Placebo local analgesic techniques and dexmedetomidine group	Dexmedetomidine	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.
Placebo local analgesic techniques and dexmedetomidine group	no Local analgesic techniques	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.
Placebo local analgesic techniques and placebo dexmedetomidine group	Normal saline	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.
Placebo local analgesic techniques and placebo dexmedetomidine group	no Local analgesic techniques	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.

Primary Outcome Measures

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