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

NCT06696586 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Fentanyl Bier Block
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bier Block; Hand Surgery

Keywords

Systemic Fentanyl Infusion; Fentanyl Added as An Adjuvant to Lidocaine

Outcome Measures

Primary Outcomes (1)

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

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

  baseline

Study Arms (2)

group 1

EXPERIMENTAL

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

Drug: Fentanyl infusion

group 2

EXPERIMENTAL

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

Drug: Fentanyl Injection

Interventions

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.

group 1

Fentanyl Injection DRUG

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

group 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Jung H, Lee KH, Jeong Y, Lee KH, Yoon S, Kim WH, Lee HJ. Effect of Fentanyl-Based Intravenous Patient-Controlled Analgesia with and without Basal Infusion on Postoperative Opioid Consumption and Opioid-Related Side Effects: A Retrospective Cohort Study. J Pain Res. 2020 Nov 24;13:3095-3106. doi: 10.2147/JPR.S281041. eCollection 2020.

  PMID: 33262644 BACKGROUND

• Glick JL, Christensen T, Park JN, McKenzie M, Green TC, Sherman SG. Stakeholder perspectives on implementing fentanyl drug checking: Results from a multi-site study. Drug Alcohol Depend. 2019 Jan 1;194:527-532. doi: 10.1016/j.drugalcdep.2018.10.017. Epub 2018 Nov 13.

  PMID: 30551090 BACKGROUND

• Farzam R, Deilami M, Jalili S, Kamali K. Comparison of Anesthesia Results between Wide Awake Local Anesthesia no Tourniquet (WALANT) and Forearm Tourniquet Bier Block in Hand Surgeries: A Randomized Clinical Trial. Arch Bone Jt Surg. 2021 Jan;9(1):116-121. doi: 10.22038/abjs.2020.49526.2487.

  PMID: 33778124 BACKGROUND

• Badeaux J, Bonanno L, Au H. Effectiveness of ondansetron as an adjunct to lidocaine intravenous regional anesthesia on tourniquet pain and postoperative pain in patients undergoing elective hand surgery: a systematic review protocol. JBI Database System Rev Implement Rep. 2015 Jan;13(1):27-38. doi: 10.11124/jbisrir-2015-1768.

  PMID: 26447005 BACKGROUND

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Abdelrahman Mostafa Ibrahim Hashim, resident doctor

CONTACT

+201094082185; abdeIrahman.16266096@med.aun.edu.eg

Ahmed Mohamed Elsonbaty, lecturer

CONTACT

+201011403456; elsonbatyahmed89@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Anaesthesia and ICU department

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04