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Intrathecal Dexmedetomidine and Acute Neuropathic Pain After Lower Limb Amputation

NCT07565662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Phantom Limb Pain
  • Neuropathic Pain
  • Lower Limb Amputation

Interventions

DRUG

Hyperbaric Bupivacaine plus Saline

Hyperbaric bupivacaine 0.5% 11 mg plus saline 0.9% 0.1 ml administered intrathecally. Total volume 2.3 ml.

DRUG

Hyperbaric Bupivacaine plus Dexmedetomidine

Hyperbaric bupivacaine 0.5% 11 mg plus dexmedetomidine 10 µg administered intrathecally. Total volume 2.3 ml.

Sponsors & Collaborators

  • Universidad Juárez Autónoma de Tabasco

    lead OTHER

Principal Investigators

  • Gabriel López-Ramírez, PhD · Universidad Juárez Autónoma de Tabasco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07565662 on ClinicalTrials.gov