Trials / Recruiting
RecruitingNCT07276867
Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- Sponsor
- National Cancer Institute, Egypt · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Intrathecal
- Dexmedetomidine
- Fentanyl
- Bupivacaine
- Spinal Anesthesia
- Above Knee Amputation
- Sarcomas
- Lower Extremity
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-10-20
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2025-12-11
- Last updated
- 2025-12-11
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT07276867. Inclusion in this directory is not an endorsement.