Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine

Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine in Femero Sciatic Block for Below Knee Surgery

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

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: dexmedetomidine as adjuvant to bupivacaine; Drug: Fentanyl as adjuvant to bupivacaine

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University, abbasia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group (dexmedetomidine group ); the sciatic and femoral nerve blocks will be achieved using A 40 ml mixture consisting of 0.25% bupivacaine and 1 µ/kg dexmedetomidine.	Drug: dexmedetomidine as adjuvant to bupivacaine; the efficacy of addition of dexmedetomidine as adjuvants to bupivacaine in femorosciatic nerve block; Other Names: adjuvants to local anesthetics
Active Comparator: group (fentanyl group ); 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.	Drug: Fentanyl as adjuvant to bupivacaine; the efficacy of addition of fentanyl as adjuvants to bupivacaine in femorosciatic nerve block; Other Names: adjuvants to local anesthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue score assessment	Score range from zero to ten , lower score indicate accepted out come	6 hours from performing the block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time of first analgesics required	analgesics requirements	Immediately after the end of the surgery and for 48 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Bupivacaine; Anesthetics; Dexmedetomidine; Fentanyl; Anesthetics, Local
• Other Study ID Numbers: FMASU MS199/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No