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

Phase 4

Not yet recruiting

• Conditions: Bier Block; Hand Surgery
• Interventions: Drug: Fentanyl infusion; Drug: Fentanyl Injection

• Registration Number: NCT06696586
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Study Start: 2025-07-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Fentanyl infusion	patients will received lidocaine with dose 250 mg and fentanyl infusion in dose of 200 µg in rate 10ml /hr using 50ml syringe pump
group 2	Fentanyl Injection	patients will receive lidocaine 250 mg in addition to fentanyl injection in dose 100 µg by shots

Primary Outcome Measures

Name	Time	Method
to compare intraoperative pain between systemic and local fentanyl using VAS score	baseline	pain will be assessed using an 11-point (0=no pain and 10=worst pain) VAS scale