NCT01727557

Anesthetic Technique for AV Fistulae Creation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• End Stage Renal Failure on Dialysis

Interventions

Type	Name	Description
PROCEDURE	regional anesthesia	Regional anesthesia will be compared to local anesthesia
PROCEDURE	local anesthesia	Regional anesthesia will be compared to local anesthesia

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-07-15
• Completion: 2016-07-15
• First posted: 2012-11-16
• Last updated: 2018-03-05

Locations

1 site across 1 country: United States