Premixed vs Sequential Injections of Lidocaine and Bupivacaine for Supraclavicular Brachial Plexus Block in Patients Undergoing Arteriovenous Fistula Creation

NCT ID: NCT06570096

Last Updated: 2025-04-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-24

Study Completion Date

2025-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to compare premixed and sequential injections of lidocaine and bupivacaine for supraclavicular brachial plexus block in patients undergoing arteriovenous fistula creation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hemodialysis is the common treatment for end-stage renal disease (ESRD) condition which improves quality of life and survival rate for this group of patients. Arteriovenous fistula (AVF) creation is the vascular access technique that provides long-term vascular access for hemodialysis patients.

Ultrasound-guided supraclavicular brachial plexus block (SCBPB) is a widely accepted and effective technique for AVF creation procedures. It provides analgesia, sympathetic blockade, optimal surgical conditions, and adequate duration of postoperative block that prevents arterial spasm and graft thrombosis. It offers higher blood flow in the radial artery and arteriovenous fistula than is achieved with infiltration anesthesia.

Lipid-soluble local anesthetics (LA) such as ropivacaine and bupivacaine are generally more potent and have a significantly longer duration of action as well as a more prolonged onset of action compared to intermediate-potency drugs such as lignocaine, mepivacaine, and prilocaine. A combination of two LAs is often used in regional blocks to utilize the different clinical properties of the drugs to achieve a faster onset and longer block duration.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premixed Sequential Lidocaine Bupivacaine Supraclavicular Brachial Plexus Block Arteriovenous Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequential Injections group

Patients will receive 10 ml of lidocaine 2% then 10 ml of bupivacaine 0.5% with a delay of 120s between injections.

Group Type EXPERIMENTAL

Lidocaine 2% then bupivacaine 0.5%

Intervention Type DRUG

Patients will receive 10 ml of lidocaine 2% then 10 ml of bupivacaine 0.5% with a delay of 120s between injections.

Premixed Injections group

Patients will receive 20 ml of freshly prepared mixtures of 10 ml of lidocaine 2% and 10 ml of bupivacaine 0.5%

Group Type ACTIVE_COMPARATOR

Lidocaine 2% and bupivacaine 0.5%

Intervention Type DRUG

Patients will receive 20 ml of freshly prepared mixtures of 10 ml of lidocaine 2% and 10 ml of bupivacaine 0.5%.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine 2% then bupivacaine 0.5%

Patients will receive 10 ml of lidocaine 2% then 10 ml of bupivacaine 0.5% with a delay of 120s between injections.

Intervention Type DRUG

Lidocaine 2% and bupivacaine 0.5%

Patients will receive 20 ml of freshly prepared mixtures of 10 ml of lidocaine 2% and 10 ml of bupivacaine 0.5%.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status III.
* Undergoing arteriovenous Fistula creation.

Exclusion Criteria

* Allergy to local anesthetics.
* Body mass index (BMI) ≥ 35 kg/m2.
* Preoperative neurological deficit.
* Neuromuscular disorder.
* Psychiatric disorder.
* Coagulation disorder.
* Congestive heart failure.
* Pregnancy.
* Infection at the site of block.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

36264PR746/7/2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.