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Intrathecal Dexmedetomidine and Acute Neuropathic Pain After Lower Limb Amputation
Sponsor: Universidad Juárez Autónoma de Tabasco
Summary
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 Casasús, Villahermosa, Tabasco, Mexico, from 30 September to 15 December 2025. Ethics approval was obtained from the Institutional Review Board (CEI/JGC/C02-25) prior to patient enrollment.
Official title: Intrathecal Dexmedetomidine Reduces Acute Neuropathic Pain After Lower Limb Amputation: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-09-30
Completion Date
2025-12-15
Last Updated
2026-10-16
Healthy Volunteers
No
Interventions
Hyperbaric Bupivacaine plus Saline
Hyperbaric bupivacaine 0.5% 11 mg plus saline 0.9% 0.1 ml administered intrathecally. Total volume 2.3 ml.
Hyperbaric Bupivacaine plus Dexmedetomidine
Hyperbaric bupivacaine 0.5% 11 mg plus dexmedetomidine 10 µg administered intrathecally. Total volume 2.3 ml.
Locations (1)
Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus
Villahermosa, Tabasco, Mexico