Arteriovenous Fistula, Bupivacaine, Lidocaine, Premixed, Sequential, Supraclavicular Brachial Plexus Block
Conditions
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.
Interventions
DRUGLidocaine 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.
DRUGLidocaine 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%.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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/m2. * Preoperative neurological deficit. * Neuromuscular disorder. * Psychiatric disorder. * Coagulation disorder. * Congestive heart failure. * Pregnancy. * Infection at the site of block.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with a complete four-nerve sensory block | With in 10 minutes intraoperatively | Percentage of participants with a complete four-nerve sensory block at 10 minutes will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of onset of motor block | 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. |
| Degree of pain | 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. |
| Time of onset of sensory block | 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. |
| Degree of patient satisfaction | 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) |
| Incidence of adverse events | 24 hours postoperatively | Incidence of adverse events such as local anesthetics systemic toxicity, PONV, hypotension, pneumothorax, or any other complication will be recorded. |
| Time to the 1st rescue analgesia | 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. |
Countries
Egypt
Outcome results
None listed