Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine

Phase 4

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: dexmedetomidine as adjuvant to bupivacaine; Drug: Fentanyl as adjuvant to bupivacaine

• Registration Number: NCT06864416
• Lead Sponsor: Ain Shams University

Brief Summary

Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit

Detailed Description

Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit, Adjuvants are those drugs which, when co-administered with local anesthetic agents, may improve the speed of onset and duration of analgesia and counteract disadvantageous effects of local anesthetics. By adding these adjuvants, the dose of local anesthetics like bupivacaine can be reduced, thereby reducing its side effects like myocardial depression, hypotension, bradycardia, heart block, and ventricular arrhythmias. Based on "Combination Wisdom", the use of adjuvants to local anesthetics has been promoted a lot .A wide variety of drugs have been used for both neuraxial and peripheral nerve blocks, and the most commonly used drug as adjuvant is the fentanyl .

The addition of dexmedetomidine during US-guided combined femoral and sciatic block for below knee surgery was associated with a prolonged duration of analgesia.

Study Timeline

• Study Start: 2024-03-11
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01
• Status Verified: 2025-01
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients aged 18-65 years.
• American Society of Anesthesiologists (ASA) physical status I-II,
• Scheduled for elective surgery below the knee.

Exclusion Criteria

• Allergies to used medications.
• Coagulopathy.
• Septic patients.
• Neurological disease.
• Respiratory or cardiac disease.
• Diabetes mellitus.
• Patients' refusal to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group (dexmedetomidine group )	dexmedetomidine as adjuvant to bupivacaine	the sciatic and femoral nerve blocks will be achieved using A 40 ml mixture consisting of 0.25% bupivacaine and 1 µ/kg dexmedetomidine.
group (fentanyl group )	Fentanyl as adjuvant to bupivacaine	the sciatic and femoral nerve blocks will be achieved using A 40 ml mixture consisting of 0.25% bupivacaine with 1 µg/kg of fentanyl.

Primary Outcome Measures

Name	Time	Method
Visual analogue score assessment	6 hours from performing the block	Score range from zero to ten , lower score indicate accepted out come

Secondary Outcome Measures

Name	Time	Method
The time of first analgesics required	Immediately after the end of the surgery and for 48 hours	analgesics requirements

Trial Locations

Locations (1)

Ain Shams University, abbasia; 🇪🇬 Cairo, Egypt