Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy：a 2× 2 Factorial Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 2,000
- Primary Endpoint
- Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Local analgesic techniques (Other)
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.
Intervention: Dexmedetomidine (Drug)
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.
Intervention: Normal saline (Drug)
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.
Intervention: Local analgesic techniques (Other)
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.
Intervention: Dexmedetomidine (Drug)
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.
Intervention: no Local analgesic techniques (Other)
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.
Intervention: Normal saline (Drug)
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.
Intervention: no Local analgesic techniques (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital