Anesthetic Technique for AV Fistulae Creation

Study Overview
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Brief Summary
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This study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. Local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done. In this case, the numbing medication will be injected directly into the area where your fistula will be made. In regional anesthesia, the numbing medication will be injected around the nerve (part of the body that gives sensation) for your arm, to make the entire arm numb. The purpose of this study is to compare the three month success rates of AV fistulae created by the two anesthesia techniques.

Detailed Description
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The primary objectives of the study are: To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula. To evaluate the immediate (within 3 days) and long-term complications three months after AV fistula construction under regional anesthesia or local anesthesia. The secondary objective of the study is to use a short questionnaire survey To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).

Conditions
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End Stage Renal Failure on Dialysis

Intervention / Treatment
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* Procedure: regional anesthesia
* Procedure: local anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21-70 years old Able to give informed consent Creation of first time AV fistula Possible 3 month follow up visit ASA-I-IV Exclusion Criteria: BMI ≥40 Repeated AV fistula creation, ASA -V, Allergic to local anesthetic agents, Significant lung and cardiac disease, Infection at the site of regional anesthesia, Pre-existing peripheral nerve damage, Significant bleeding disorders,

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local anesthesia<br> | Procedure: regional anesthesia<br>* Regional anesthesia will be compared to local anesthesia<br>|
| Active Comparator: regional anesthesia<br> | Procedure: local anesthesia<br>* Regional anesthesia will be compared to local anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AV fistula success rate | To evaluate the three-month success rate for AV fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. Success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. Successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created AV fistula. | Three months from the day of creation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term comfort level | To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia). | Within three days of procedure | 
| Short term safety, number of post operative complications | b) To evaluate the immediate complications (within 3 days)after AV fistula construction under regional anesthesia or local anesthesia. | Three days after the creation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis and AV fistula