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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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06696586
Enrollment
84
Registered
2024-11-20
Start date
2025-07-01
Completion date
2027-01-01
Last updated
2025-04-18

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

Conditions

Bier Block, Hand Surgery

Keywords

Systemic Fentanyl Infusion, Fentanyl Added as An Adjuvant to Lidocaine

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

Interventions

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

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

The patients will be randomly allocated to one of two groups; each group consisted of 42 patients. Randomization will be performed using a closed envelope method

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
to compare intraoperative pain between systemic and local fentanyl using VAS scorebaselinepain will be assessed using an 11-point (0=no pain and 10=worst pain) VAS scale

Contacts

Primary ContactAbdelrahman Mostafa Ibrahim Hashim, resident doctor
abdeIrahman.16266096@med.aun.edu.eg+201094082185
Backup ContactAhmed Mohamed Elsonbaty, lecturer
elsonbatyahmed89@gmail.com+201011403456

Outcome results

None listed

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