Clinical trial · Interventional
Perioperative Multimodal Analgesia for Supratentorial Craniotomy
Perioperative Multimodal Analgesia for Supratentorial Craniotomy：Protocol for a 2× 2 Factorial Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesia | — | UNRESOLVED | — |
| Postoperative Pain | — | UNRESOLVED | — |
| Supratentorial Brain Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexmedetomidine | Drug | — | UNRESOLVED |
| Scalp-Nerve Block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Scalp nerve blocks plus placebo dexmedetomidine infusion
- description
- Patients in this group will receive a scalp nerve block with liposomal bupivacaine before surgery. They will receive a continuous intravenous infusion of normal saline (placebo) at the same rate and via identical infusion pumps as used for the dexmedetomidine infusion in the active comparator group.
- interventionNames
- Procedure: Scalp-Nerve Block
- type
- EXPERIMENTAL
- label
- Placebo scalp nerve blocks plus dexmedetomidine infusion
- description
- Patients in this group will receive a sham block (no local anesthetic or saline injected). They will receive a continuous intravenous infusion of dexmedetomidine, starting from anesthesia induction until dural closure at a rate of 0.4 μg/kg/h, followed by a maintenance dose of 0.05 μg/kg/h for 48 hours postoperatively.
- interventionNames
- Drug: Dexmedetomidine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available