Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fentanyl + Dexmedetomidine, Fentanyl.
- Who it may be relevant to
- Registry conditions: Intrathecal, Dexmedetomidine, Fentanyl, Bupivacaine. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity: A Randomized, Comparative Study
Overview
The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.
Detailed description
Above-knee amputation (AKA) for advanced lower limb (LL) sarcomas has a high risk of chronic pain syndromes, like phantom limb pain, and is associated with severe perioperative pain. Effective analgesia is essential for patient comfort, early rehabilitation, and improved outcomes.
Dexmedetomidine (DEX), a highly selective α2-adrenergic agonist, is a promising intrathecal (IT) adjuvant.
The combination of DEX and fentanyl may produce synergistic effects, extending block duration and improving perioperative analgesia while minimizing individual drug doses. The current approach is particularly relevant in oncologic surgeries like AKA, where optimal pain control is critical. However, supportive evidence exists in various surgical contexts.
Interventions
- Drug Fentanyl + Dexmedetomidine
Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine. - Drug Fentanyl
Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.
Primary outcome measures
- Time to first rescue analgesia [Time frame: 24 hours postoperatively]
Secondary outcome measures (4)
- Total amount of morphine [Time frame: 24 hours postoperatively]
- Intraoperative fentanyl consumption [Time frame: Intraoperatively]
- Degree of pain [Time frame: 24 hours postoperatively]
- Incidence of adverse events [Time frame: 24 hours postoperatively]
Eligibility criteria
Inclusion criteria
- Age from 18 to 60 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status of II-III.
- Height between 150-185 cm.
- Body mass index between 18-35 kg/m².
- Scheduled for above-knee amputation due to lower limb sarcomas.
Exclusion criteria
- Allergy to any of the investigated drugs.
- History of heart block, arrhythmia, or ongoing therapy with beta- or calcium channel- blockers, or angiotensin-converting-enzyme inhibitors.
- Contraindications to spinal anesthesia.
- Pregnancy or lactation.
- Presence of psychiatric illness or chronic pain conditions.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- National Cancer Institute — Cairo
Identifiers
NCT: NCT07276867 · AP2509-501-125-203