Anesthetic Technique for AV Fistulae Creation

Montefiore Medical Center10 enrolled

Overview

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.

The primary objectives of the study are: 1. 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. 2. 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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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,

Outcomes

Primary Outcomes

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.

Time frame: Three months from the day of creation

Secondary Outcomes

Short term comfort level

To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).

Time frame: 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.

Time frame: Three days after the creation