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NCT Number: NCT06570096

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

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

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Key information

Conditions

Premixed Arteriovenous Fistula Arteriovenous Malformations Bupivacaine Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Lidocaine Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sequential Supraclavicular Brachial Plexus Block Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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%.

Primary outcomes

  1. Percentage of participants with a complete four-nerve sensory block

    Time frame: With in 10 minutes intraoperatively

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

Secondary outcomes

  1. Time of onset of sensory block

    Time frame: Intraoperatively

    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.

  2. Time of onset of motor block

    Time frame: Intraoperatively

    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.

  3. Degree of pain

    Time frame: 24 hours postoperatively

    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.

  4. Time to the 1st rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated) will be recorded.

  5. Degree of patient satisfaction

    Time frame: 24 hours postoperatively

    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)

  6. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as local anesthetics systemic toxicity, PONV, hypotension, pneumothorax, or any other complication will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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