Anesthetic Technique for AV Fistulae Creation

Not Applicable

Terminated

• Conditions: End Stage Renal Failure on Dialysis
• Interventions: Procedure: local anesthesia; Procedure: regional anesthesia

• Registration Number: NCT01727557
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-16
• Primary Completion: 2016-07-15
• Study Completion: 2016-07-15
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
regional anesthesia	local anesthesia	-
Local anesthesia	regional anesthesia	-

Primary Outcome Measures

Name	Time	Method
AV fistula success rate	Three months from the day of creation	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States