Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Post Operative Pain

Treatments: Drug: dexmedetomidine as adjuvant to bupivacaine; Drug: Fentanyl as adjuvant to bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06864416

FMASU MS199/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

group (dexmedetomidine group )

Active Comparator group

Description:

the sciatic and femoral nerve blocks will be achieved using A 40 ml mixture consisting of 0.25% bupivacaine and 1 µ/kg dexmedetomidine.

Treatment:

Drug: dexmedetomidine as adjuvant to bupivacaine

group (fentanyl group )

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl as adjuvant to bupivacaine