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| ID | Type | Description | Link |
|---|---|---|---|
| CEI/JGC/C02-25 | Other Identifier | HRAE Dr. Juan Graham Casasus |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Analgesic Rescue | Time in hours from spinal block to first postoperative analgesic rescue request. | 48 hours postoperatively |
| Proportion Requiring Analgesic Rescue | Proportion of patients requiring at least one analgesic rescue dose during the postoperative period. | 48 hours postoperatively |
| Heart Rate | Heart rate measured in beats per minute during the first 4 hours post-block. | 4 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. | 48 hours postoperatively |
| Duration of Sensory Block | Duration of sensory block assessed by Hollmen scale. Measured at multiple timepoints through 48 hours postoperatively. | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
Patient refusal of anesthetic procedure
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel López-Ramírez, PhD | Universidad Juárez Autónoma de Tabasco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus | Villahermosa | Tabasco | 86126 | Mexico |
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Hyperbaric Bupivacaine plus Dexmedetomidine | Drug | Hyperbaric bupivacaine 0.5% 11 mg plus dexmedetomidine 10 µg administered intrathecally. Total volume 2.3 ml. |
|
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D017670 |
| Sodium Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |