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

Premixed Versus Sequential Injections of Lidocaine and Bupivacaine for Supraclavicular Brachial Plexus Block in Patients Undergoing Arteriovenous Fistula Creation: A Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Supraclavicular Brachial Plexus Block; Arteriovenous Fistula; Lidocaine; Bupivacaine; Premixed; Sequential
• Intervention / Treatment: Drug: Lidocaine 2% then bupivacaine 0.5%; Drug: Lidocaine 2% and bupivacaine 0.5%

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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%	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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of onset of sensory block	Time of onset of sensory block is defined as time interval between end of local anesthetics injection and complete loss of sensation to pin prick in all four nerve distribution areas, and the duration of sensory block is defined as the time interval between onset of sensory block and reappearance of pinprick sensation in all four nerve distribution areas.	Intraoperatively
Time of onset of motor block	Time of onset of motor block is defined as the time interval between the completion of local anesthetics injection and the inability of patient to move the elbow, wrist and fingers of the operating limb.	Intraoperatively
Degree of pain	Degree of pain will be recorded using numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). It will be assessed every 2 hours for 6 hours then every 4 hours for 24 hours postoperatively.	24 hours postoperatively
Time to the 1st rescue analgesia	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated) will be recorded.	24 hours postoperatively
Degree of patient satisfaction	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)	24 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as local anesthetics systemic toxicity, PONV, hypotension, pneumothorax, or any other complication will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2024
• Primary Completion (Actual): March 16, 2025
• Study Completion (Actual): March 16, 2025

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Bupivacaine; Lidocaine
• Other Study ID Numbers: 36264PR746/7/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No