Analgesia, Postoperative Pain, Supratentorial Brain Tumor
Conditions
Keywords
multimodal analgesia, postoperative acute pain
Brief summary
This randomized clinical trial aims to evaluate the effectiveness of scalp nerve blocks and dexmedetomidine in reducing opioid use and preventing postoperative delirium in patients undergoing supratentorial brain tumor surgery. A total of 2000 patients will be randomly assigned to one of four groups, receiving either active treatments, placebos, or their combinations. The main outcome measured will be the amount of opioid pain medication needed after surgery.
Detailed description
This single-center, double-blind, placebo-controlled trial employs a 2x2 factorial design to evaluate two non-opioid interventions: preoperative scalp nerve blocks and perioperative dexmedetomidine infusion. Eligible patients scheduled for elective supratentorial tumor resection will be randomized into four groups: 1) scalp nerve blocks plus placebo dexmedetomidine infusion; 2) placebo scalp nerve blocks plus dexmedetomidine infusion; 3)both active treatments; and 4) double placebo. The primary outcomes are cumulative sufentanil consumption via patient-controlled analgesia during the first 48 postoperative hours. Secondary outcomes include the incidence of postoperative delirium within 3 days assessed using CAM-ICU/3D-CAM, pain scores, total perioperative opioid use, quality of recovery, and persistent incisional pain. Results will provide evidence for optimizing analgesia while minimizing opioid-related complications in neurosurgical patients.
Interventions
DRUGDexmedetomidine
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.
PROCEDUREScalp-Nerve Block
The 10ml 1.33% liposomal bupivacaine will be diluted into a 20ml syringe. As for scalp nerve block, each nerve will be blocked separately with 1-2 mL 0.67% liposomal bupivacaine.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 * Inability to communicate, * Preoperative pain in the surgical region * Severe hepatic or renal dysfunction * Severe bradycardia (heart rate\<40 beats/min) * Sick sinus syndrome or second- to-third degree atrioventricular block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively | 48 hours postoperatively | Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively |
Contacts
CONTACTMin Zeng, Dr
CONTACTMuhan Li, Dr
PRINCIPAL_INVESTIGATORYuming Peng, Dr
Beijing Tiantan Hospital
Outcome results
None listed