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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06864416
Enrollment
20
Registered
2025-03-07
Start date
2024-03-11
Completion date
2024-11-01
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

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.

Interventions

DRUGdexmedetomidine as adjuvant to bupivacaine

the efficacy of addition of dexmedetomidine as adjuvants to bupivacaine in femorosciatic nerve block

DRUGFentanyl as adjuvant to bupivacaine

the efficacy of addition of fentanyl as adjuvants to bupivacaine in femorosciatic nerve block

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue score assessment6 hours from performing the blockScore range from zero to ten , lower score indicate accepted out come

Secondary

MeasureTime frameDescription
The time of first analgesics requiredImmediately after the end of the surgery and for 48 hoursanalgesics requirements

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026