Clinical trial NCT06570096: Premixed vs Sequential Injections of Lidocaine and Bupivacaine for Supraclavicular Brachial Plexus Block in Patients Undergoing Arteriovenous Fistula Creation
Official title: Premixed Versus Sequential Injections of Lidocaine and Bupivacaine for Supraclavicular Brachial Plexus Block in Patients Undergoing Arteriovenous Fistula Creation: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premixed
Sequential
Lidocaine
Bupivacaine
Supraclavicular Brachial Plexus Block
Arteriovenous Fistula
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with a complete four-nerve sensory block
timeFrame: With in 10 minutes intraoperatively
Secondary outcomes:
measure: Time of onset of sensory block
timeFrame: Intraoperatively
measure: Time of onset of motor block
timeFrame: Intraoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: