Premixed Versus Sequential Injections of Lidocaine and Bupivacaine for Supraclavicular Brachial Plexus Block in Patients Undergoing Arteriovenous Fistula Creation: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Percentage of participants with a complete four-nerve sensory block
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/m
- •Preoperative neurological deficit.
- •Neuromuscular disorder.
- •Psychiatric disorder.
- •Coagulation disorder.
- •Congestive heart failure.
- •Pregnancy.
- •Infection at the site of block.
Arms & Interventions
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.
Intervention: Lidocaine 2% then bupivacaine 0.5% (Drug)
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%
Intervention: Lidocaine 2% and bupivacaine 0.5% (Drug)
Outcomes
Primary Outcomes
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
- Time of onset of sensory block(Intraoperatively)
- Degree of pain(24 hours postoperatively)
- Time of onset of motor block(Intraoperatively)
- Time to the 1st rescue analgesia(24 hours postoperatively)
- Incidence of adverse events(24 hours postoperatively)
- Degree of patient satisfaction(24 hours postoperatively)
Investigators
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University