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NCT Number: NCT06696586

Comparison Between Effect of Systemic Fentanyl Infusion and Fentanyl Added as An Adjuvant to Lidocaine in Bier Block For Controlling Pain in Patients Undergoing Hand Surgeries

Injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain.

Various techniques of regional anesthesia are frequently used for upper extremity surgery. Specifically, intravenous regional anesthesia, the Bier block, is an effective anesthetic technique. This technique, developed by Dr August Bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. However, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. Because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome the aim of this study To evaluate the effect of Systemic Fentanyl Infusion compared to addition of Fentanyl as An Adjuvant to Lidocaine in Bier Block for Controlling Pain in Patients Undergoing Hand Surgeries

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain.

Various techniques of regional anesthesia are frequently used for upper extremity surgery. Specifically, intravenous regional anesthesia, the Bier block, is an effective anesthetic technique. This technique, developed by Dr August Bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. However, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. Because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients age from 18 years to 40 years
  • Both sex
  • Patients of the American Society of Anesthesiologists (ASA) physical Status class I and II
  • BMI less than 40

Exclusion criteria

  • • Patients who refuse to participate in study.
  • Uncooperative patients.
  • Patient with crush injury
  • Peripheral vascular, neurological or muscle diseases.
  • Coagulation disorders that affect the blood's clotting activities e.g.: Hemophilia.
  • History of hypersensitivity to the drugs being evaluated

Treatment and study plan

Fentanyl infusion

Drug

will received lidocaine with dose 250 mg and fentanyl infusion in dose of 200 µg in rate 10ml /hr using 50ml syringe pump.

Fentanyl Injection

Drug

will receive lidocaine 250 mg in addition to fentanyl injection in dose 100 µg by shots

Primary outcomes

  1. to compare intraoperative pain between systemic and local fentanyl using VAS score

    Time frame: baseline

    pain will be assessed using an 11-point (0=no pain and 10=worst pain) VAS scale

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Mostafa Ibrahim Hashim, resident doctor

CONTACT

[email protected]

+201094082185

Ahmed Mohamed Elsonbaty, lecturer

CONTACT

[email protected]

+201011403456

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2024
Registry last updated
Apr 18, 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.

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