Skip to main content
OpenTrials
Completed

NCT Number: NCT07565662

Intrathecal Dexmedetomidine and Acute Neuropathic Pain After Lower Limb Amputation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Phantom Limb Pain Lower Limb Amputation Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Phantom Limb Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus

Villahermosa, Tabasco, 86126, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Hyperbaric Bupivacaine plus Saline

Drug

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

Hyperbaric Bupivacaine plus Dexmedetomidine

Drug

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

Primary outcomes

  1. Time to First Analgesic Rescue

    Time frame: 48 hours postoperatively

    Time in hours from spinal block to first postoperative analgesic rescue request.

  2. Proportion Requiring Analgesic Rescue

    Time frame: 48 hours postoperatively

    Proportion of patients requiring at least one analgesic rescue dose during the postoperative period.

  3. Heart Rate

    Time frame: 4 hours postoperatively

    Heart rate measured in beats per minute during the first 4 hours post-block.

  4. Duration of Motor Block

    Time frame: 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.

  5. Duration of Sensory Block

    Time frame: 48 hours postoperatively

    Duration of sensory block assessed by Hollmen scale. Measured at multiple timepoints through 48 hours postoperatively.

Secondary outcomes

  1. Incidence of Acute Neuropathic Pain

    Time frame: 48 hours postoperatively

    Incidence of acute neuropathic pain assessed by DN4 screening tool (0-10, score ≥4 indicates neuropathic pain component). Reported as exploratory secondary outcome.

Sponsors and collaborators

Lead sponsor

Universidad Juárez Autónoma de Tabasco

Other

Registry information

Official study title

Intrathecal Dexmedetomidine Reduces Acute Neuropathic Pain After Lower Limb Amputation: A Randomized Controlled Trial

Acronym: DEX-RCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.