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

NCT06570096 | Completed

• 1 other identifier: 36264PR746/7/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Premixed; Sequential; Lidocaine; Bupivacaine; Supraclavicular Brachial Plexus Block; Arteriovenous Fistula

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with a complete four-nerve sensory block

  Percentage of participants with a complete four-nerve sensory block at 10 minutes will be recorded.

  With in 10 minutes intraoperatively

Secondary Outcomes (6)

• Time of onset of sensory block

  Intraoperatively

• Time of onset of motor block

  Intraoperatively

• Degree of pain

  24 hours postoperatively

• Time to the 1st rescue analgesia

  24 hours postoperatively

• Degree of patient satisfaction

  24 hours postoperatively

Study Arms (2)

Sequential Injections group

EXPERIMENTAL

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

Drug: Lidocaine 2% then bupivacaine 0.5%

Premixed Injections group

ACTIVE COMPARATOR

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

Drug: Lidocaine 2% and bupivacaine 0.5%

Interventions

Lidocaine 2% then bupivacaine 0.5% DRUG

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

Sequential Injections group

Lidocaine 2% and bupivacaine 0.5% DRUG

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

Premixed Injections group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: August 24, 2024
• Primary Completion: March 16, 2025
• Study Completion: March 16, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)