Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity

National Cancer Institute, Egypt

Status: Enrolling

Conditions: Above Knee Amputation; Intrathecal; Lower Extremity; Fentanyl; Spinal Anesthesia; Bupivacaine; Dexmedetomidine; Sarcomas

Treatments: Drug: Fentanyl + Dexmedetomidine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT07276867

AP2509-501-125-203

Details and patient eligibility

About

The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Group DF

Experimental group

Description:

Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.

Treatment:

Drug: Fentanyl + Dexmedetomidine

Group F

Active Comparator group

Description:

Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.

Treatment:

Drug: Fentanyl