Intrathecal dexmedetomidine plus fentanyl with bupivacaine for spinal anesthesia during above-knee amputation
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | National Cancer Institute, Egypt Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07276867 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo
- National Cancer Institute — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mai M Elrawas, MD
- Email: mai.elrawas@nci.cu.edu.eg
- Phone: 00201222177242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.