An interventional study of Dexmedetomidine and Scalp-Nerve Block in Postoperative Pain, Analgesia and Supratentorial Brain Tumor, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
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.
Procedure: Scalp-Nerve Block
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.
Drug: Dexmedetomidine
Patients in this group will receive scalp nerve block before surgery with liposomal bupivacaine. They will also receive a continuous intravenous infusion of dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from anesthesia induction until dural closure, followed by a maintenance dose of 0.05 μg/kg/h for 48 hours postoperatively.
Drug: Dexmedetomidine · Procedure: Scalp-Nerve Block
Patients in this group will receive a sham scalp nerve block (no injection). The patients in this group will not receive scalp nerve block. From the start of surgery until 48 hours postoperatively, 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.
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.
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.
Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively
Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively
Time frame: 48 hours postoperatively
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Beijing Tiantan Hospital