Skip to main content
OpenTrials
Completed

NCT Number: NCT06864416

Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University, abbasia

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dexmedetomidine as adjuvant to bupivacaine

Drug

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

Other names: adjuvants to local anesthetics

Fentanyl as adjuvant to bupivacaine

Drug

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

Other names: adjuvants to local anesthetics

Primary outcomes

  1. Visual analogue score assessment

    Time frame: 6 hours from performing the block

    Score range from zero to ten , lower score indicate accepted out come

Secondary outcomes

  1. The time of first analgesics required

    Time frame: Immediately after the end of the surgery and for 48 hours

    analgesics requirements

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.