Intrathecal Dexmedetomidine Reduces Acute Neuropathic Pain After Lower Limb Amputation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to First Analgesic Rescue
研究概览
简要总结
This randomized controlled trial evaluated the effect of adding intrathecal dexmedetomidine (10 µg) to hyperbaric bupivacaine (11 mg) for spinal anesthesia in patients undergoing lower limb amputation. Thirty patients (ASA I-III) scheduled for elective supra- or infracondylar amputation were randomly allocated to two groups: Control Group (n=15) received hyperbaric bupivacaine 11 mg plus saline 0.9%, and Experimental Group (n=15) received hyperbaric bupivacaine 11 mg plus dexmedetomidine 10 µg. Primary outcomes were duration of motor and sensory neuraxial block and postoperative analgesia at 48 hours. As a prespecified exploratory secondary outcome, incidence of acute neuropathic pain was assessed using the DN4 screening tool at 48 hours. The study was conducted at the Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus, Villahermosa, Tabasco, Mexico, from April to October 2025. Ethics approval was obtained from the Institutional Review Board (CEI/JGC/C02-25) prior to patient enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients scheduled for elective supra- or infracondylar lower limb amputation
- •Age 18 to 65 years
- •ASA physical status I-III
- •Acceptance of neuraxial anesthetic technique
排除标准
- •Patient refusal of anesthetic procedure
- •Prolonged coagulation times
- •Anatomical abnormalities of the spine
- •ASA IV classification
- •Atrioventricular block grade 2 or 3 without pacemaker
- •Neurological deterioration (Glasgow score less than 8)
- •Hemodynamic instability
研究组 & 干预措施
Control Group - Bupivacaine Alone
Patients in this arm received hyperbaric bupivacaine 0.5% 11 mg plus saline 0.9% 0.1 ml administered intrathecally via spinal injection at level L2-L3. Total volume: 2.3 ml.
干预措施: Hyperbaric Bupivacaine plus Saline (Drug)
Experimental Group - Bupivacaine plus Dexmedetomidine
Patients in this arm received hyperbaric bupivacaine 0.5% 11 mg plus dexmedetomidine 10 µg administered intrathecally via spinal injection at level L2-L3. Total volume: 2.3 ml.
干预措施: Hyperbaric Bupivacaine plus Dexmedetomidine (Drug)
结局指标
主要结局
Time to First Analgesic Rescue
时间窗: 48 hours postoperatively
Time in hours from spinal block to first postoperative analgesic rescue request.
Proportion Requiring Analgesic Rescue
时间窗: 48 hours postoperatively
Proportion of patients requiring at least one analgesic rescue dose during the postoperative period.
Heart Rate
时间窗: 4 hours postoperatively
Heart rate measured in beats per minute during the first 4 hours post-block.
Duration of Motor Block
时间窗: 48 hours postoperatively
Duration of motor block assessed by modified Bromage scale (0-3, higher scores indicate greater motor block). Measured at multiple timepoints through 48 hours postoperatively.
Duration of Sensory Block
时间窗: 48 hours postoperatively
Duration of sensory block assessed by Hollmen scale. Measured at multiple timepoints through 48 hours postoperatively.
次要结局
- Incidence of Acute Neuropathic Pain(48 hours postoperatively)
研究者
Gabriel López
Professor-Researcher, División Académica de Ciencias de la Salud
Universidad Juárez Autónoma de Tabasco