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

Tanta University

Status: Completed

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

Treatments: Drug: Lidocaine 2% then bupivacaine 0.5%; Drug: Lidocaine 2% and bupivacaine 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT06570096

36264PR746/7/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Sequential Injections group

Experimental group

Description:

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

Treatment:

Drug: Lidocaine 2% then bupivacaine 0.5%

Premixed Injections group

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine 2% and bupivacaine 0.5%