Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Normal saline, Local analgesic techniques, no Local analgesic techniques.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Analgesia, Supratentorial Brain Tumor. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy：a 2× 2 Factorial Randomized Clinical Trial
Overview
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.
Interventions
- 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. - 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 Local analgesic techniques
As for scalp nerve block, each nerve will be blocked separately with 1-2 mL of 0.67 % liposomal bupivacaine - Other no Local analgesic techniques
No Local analgesic techniques will be given.
Primary outcome measures
- Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively. [Time frame: 48 hours postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06406829 · 2024007