An interventional study of Hyperbaric Bupivacaine plus Saline and Hyperbaric Bupivacaine plus Dexmedetomidine in Phantom Limb Pain, Neuropathic Pain and Lower Limb Amputation, sponsored by Universidad Juárez Autónoma de Tabasco. Completed at 1 site in Mexico. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Universidad Juárez Autónoma de Tabasco · Not applicable, Interventional, and Treatment
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Universidad Juárez Autónoma de Tabasco is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient refusal of anesthetic procedure
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Hyperbaric Bupivacaine plus Saline
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.
Drug: Hyperbaric Bupivacaine plus Dexmedetomidine
Hyperbaric bupivacaine 0.5% 11 mg plus saline 0.9% 0.1 ml administered intrathecally. Total volume 2.3 ml.
Hyperbaric bupivacaine 0.5% 11 mg plus dexmedetomidine 10 µg administered intrathecally. Total volume 2.3 ml.
Proportion Requiring Analgesic Rescue
Proportion of patients requiring at least one analgesic rescue dose during the postoperative period.
Time frame: 48 hours postoperatively
Duration of Motor Block
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.
Time frame: 48 hours postoperatively
Duration of Sensory Block
Duration of sensory block assessed by Hollmen scale. Measured at multiple timepoints through 48 hours postoperatively.
Time frame: 48 hours postoperatively
Incidence of Acute Neuropathic Pain
Incidence of acute neuropathic pain assessed by DN4 screening tool (0-10, score ≥4 indicates neuropathic pain component). Reported as exploratory secondary outcome.
Time frame: 48 hours postoperatively
Heart Rate
Heart rate measured in beats per minute during the first 4 hours post-block.
Time frame: 4 hours postoperatively
Plan to share: Yes — De-identified individual participant data underlying the published results will be available from the corresponding author on reasonable request.
Supporting information: Study protocol, Informed consent form
Time frame: Data will be available beginning 3 months after article publication and ending 5 years after publication.
Access criteria: De-identified individual participant data will be shared with researchers who provide a methodologically sound proposal, approved by the corresponding author, for the purpose of verifying the published results or conducting individual-participant-data meta-analysis. Requests should be directed to the corresponding author.
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Dec 2025, 2 months.
Of 61 non-industry interventional studies with no phase under Phantom Limb, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 2 months is below that.
Counting every sponsor, half of 64 studies reached it within 34 months; a quarter within 13 and three quarters within 50.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: start Apr 2025 → Sep 2025, primary completion Oct 2025 → Dec 2025 and completion Oct 2025 → Dec 2025.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Universidad Juárez Autónoma de Tabasco