Perioperative Multimodal Analgesia for Supratentorial Craniotomy：Protocol for a 2× 2 Factorial Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 65 years
- •American Society of Anesthesiologists physical status I to III
- •Scheduled to undergo elective supratentorial tumor resection
排除标准
- •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
研究组 & 干预措施
Both active treatments
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.
干预措施: Dexmedetomidine (Drug)
Scalp nerve blocks plus placebo dexmedetomidine infusion
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.
干预措施: Scalp-Nerve Block (Procedure)
Placebo scalp nerve blocks plus dexmedetomidine infusion
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.
干预措施: Dexmedetomidine (Drug)
Both active treatments
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.
干预措施: Scalp-Nerve Block (Procedure)
Double placebo
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.
结局指标
主要结局
Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively
时间窗: 48 hours postoperatively
Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively
次要结局
未报告次要终点
研究者
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital