Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy

Capital Medical University

Status: Not yet enrolling

Conditions: Postoperative Pain; Analgesia; Supratentorial Brain Tumor

Treatments: Other: no Local analgesic techniques; Drug: Dexmedetomidine; Drug: Normal saline; Other: Local analgesic techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT06406829

2024007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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2,000 participants in 4 patient groups, including a placebo group

Local analgesic techniques + dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Other: Local analgesic techniques

Drug: Dexmedetomidine

Local analgesic techniques and placebo dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Other: Local analgesic techniques

Drug: Normal saline

Placebo local analgesic techniques and dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Other: no Local analgesic techniques

Placebo local analgesic techniques and placebo dexmedetomidine group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal saline

Other: no Local analgesic techniques