Phantom Limb PainDEX-RCTNCT07565662
Intrathecal Dexmedetomidine and Acute Neuropathic Pain After Lower Limb Amputation
A study testing Hyperbaric Bupivacaine plus Saline and Hyperbaric Bupivacaine plus Dexmedetomidine in people with Phantom Limb Pain and Neuropathic Pain, run by Universidad Juárez Autónoma de Tabasco at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phantom Limb Pain, Neuropathic Pain, Lower Limb Amputation
- What is being tested?
- Hyperbaric Bupivacaine plus Saline and Hyperbaric Bupivacaine plus Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 30 Sep 2025to 15 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus
Villahermosa, Tabasco, 86126
About this study
Official title: Intrathecal Dexmedetomidine Reduces Acute Neuropathic Pain After Lower Limb Amputation: A Randomized Controlled Trial
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.
- Conditions
- Phantom Limb Pain, Neuropathic Pain, Lower Limb Amputation
- Being tested
- Hyperbaric Bupivacaine plus Saline, Hyperbaric Bupivacaine plus Dexmedetomidine
- Medical subject headings
- Phantom Limb, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Bupivacaine plus SalineDrug
Hyperbaric bupivacaine 0.5% 11 mg plus saline 0.9% 0.1 ml administered intrathecally. Total volume 2.3 ml.
Hyperbaric Bupivacaine plus DexmedetomidineDrug
Hyperbaric bupivacaine 0.5% 11 mg plus dexmedetomidine 10 µg administered intrathecally. Total volume 2.3 ml.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - Bupivacaine Alone | Active comparator | 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. Receives: Drug: Hyperbaric Bupivacaine plus Saline |
| Experimental Group - Bupivacaine plus Dexmedetomidine | Experimental | 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. Receives: Drug: Hyperbaric Bupivacaine plus Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion Requiring Analgesic Rescue
Proportion of patients requiring at least one analgesic rescue dose during the postoperative period.
Measured: 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.
Measured: 48 hours postoperatively
Duration of Sensory Block
Duration of sensory block assessed by Hollmen scale. Measured at multiple timepoints through 48 hours postoperatively.
Measured: 48 hours postoperatively
Secondary outcomes (2)
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.
Measured: 48 hours postoperatively
Heart Rate
Heart rate measured in beats per minute during the first 4 hours post-block.
Measured: 4 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start30 Sep 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Juárez Autónoma de Tabasco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel López, Universidad Juárez Autónoma de Tabasco
- Investigators
- Gabriel López-Ramírez, PhD, Principal investigator, Universidad Juárez Autónoma de Tabasco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565662
- Sponsor's protocol ID
- JI-PG348
- Other IDs
- CEI/JGC/C02-25
- Acronym
- DEX-RCT
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be available from the corresponding author on reasonable request.