Clinical Trial

Intrathecal Dexmedetomidine and Acute Neuropathic Pain After Lower Limb Amputation

Study acronym: DEX-RCT
Completed
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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 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.
Trial Details
NCT Number NCT07565662
Lead Sponsor Universidad Juárez Autónoma de Tabasco
Conditions Phantom Limb Pain, Neuropathic Pain, Lower Limb Amputation
Enrollment 30 participants
Start Date 2025-04-01
Primary Completion 2025-10-31 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-04