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

NCT ID: NCT07276867

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2026-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group DF

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

Group Type: EXPERIMENTAL

Fentanyl + Dexmedetomidine

Intervention Type: DRUG

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

Group F

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

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

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

Interventions

Fentanyl + Dexmedetomidine

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

Intervention Type: DRUG

Fentanyl

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Mai Mohamed El Rawas

Assistant professor of Anaesthesia, Intensive Care and Pain Management, National Cancer Institute, Cairo University Cairo University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer Institute

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mai M Elrawas, MD

Role: CONTACT

mai.elrawas@nci.cu.edu.eg

00201222177242

Facility Contacts

Mai M Elrawas, MD

Role: primary

mai.elrawas@nci.cu.edu.eg

00201222177242

Other Identifiers

AP2509-501-125-203

Identifier Type: -

Identifier Source: org_study_id