Intrathecal dexmedetomidine plus fentanyl with bupivacaine for spinal anesthesia during above-knee amputation
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
Run by National Cancer Institute, Egypt · NCT07276867 · Data updated 2026-11-12
This trial will test whether adding intrathecal dexmedetomidine to fentanyl and bupivacaine gives better and longer pain relief after above-knee amputation for adults with lower-limb sarcoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 58 (estimated) |
| Sponsor | National Cancer Institute, Egypt Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | October 20, 2025 |
| Main results expected | April 1, 2026 |
| Study ends | April 1, 2026 |
| Registry record updated | December 11, 2025 |
| Trial ID | NCT07276867 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–60 years old with lower-limb sarcoma scheduled for above-knee amputation who are ASA II–III, within the specified height and BMI ranges, and have no contraindications to spinal anesthesia.
✕Probably not a fit
Patients with contraindications to spinal anesthesia, pregnancy or lactation, significant cardiac conduction disease or interacting cardiovascular medications, chronic pain or psychiatric disorders, or those not undergoing above-knee amputation for sarcoma are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults aged 18–60 scheduled for above-knee amputation for lower-extremity sarcoma receive spinal anesthesia with hyperbaric bupivacaine and either fentanyl alone or fentanyl plus intrathecal dexmedetomidine. The study compares postoperative analgesia duration, block characteristics, and perioperative pain control between the two groups. Standard eligibility criteria exclude patients with contraindications to spinal anesthesia, significant cardiac arrhythmias, pregnancy, chronic pain disorders, or psychiatric illness. Procedures are performed at the National Cancer Institute in Cairo with perioperative monitoring and standardized anesthesia protocols.
Why it matters
Potential benefit: If successful, the combination could provide longer-lasting pain relief, reduce opioid needs, and improve early rehabilitation after above-knee amputation.
How similar studies have gone: Previous studies in other surgical settings have shown intrathecal dexmedetomidine can prolong block duration and improve analgesia, but evidence specifically for above-knee amputation is limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
National Cancer Institute
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Mai M Elrawas, MD
- Email: mai.elrawas@nci.cu.edu.eg
- Phone: 00201222177242
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.