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

NCT ID: NCT06696586

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-01-01

Brief Summary

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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

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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

Conditions

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Bier Block Hand Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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

Study Groups

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group 1

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 Type EXPERIMENTAL

Fentanyl infusion

Intervention Type 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 2

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

Group Type EXPERIMENTAL

Fentanyl Injection

Intervention Type DRUG

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

Interventions

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Fentanyl infusion

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

Intervention Type DRUG

Fentanyl Injection

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrahman Mostafa Ibrahim

resident doctor at Anaesthesia and ICU department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Abdelrahman Mostafa Ibrahim Hashim, resident doctor

Role: CONTACT

+201094082185

Ahmed Mohamed Elsonbaty, lecturer

Role: CONTACT

+201011403456

References

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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.

Reference Type BACKGROUND
PMID: 33262644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30551090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33778124 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26447005 (View on PubMed)

Other Identifiers

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Fentanyl Bier Block

Identifier Type: -

Identifier Source: org_study_id

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