Anesthetic Technique for AV Fistulae Creation

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.

Study Overview

• Status: Terminated
• Conditions: End Stage Renal Failure on Dialysis
• Intervention / Treatment: Procedure: regional anesthesia; Procedure: local anesthesia

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local anesthesia	Procedure: regional anesthesia; Regional anesthesia will be compared to local anesthesia
Active Comparator: regional anesthesia	Procedure: local anesthesia; Regional anesthesia will be compared to local anesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): July 15, 2016
• Study Completion (Actual): July 15, 2016

Study Registration Dates

• First Submitted: June 8, 2012
• First Submitted That Met QC Criteria: November 15, 2012
• First Posted (Estimate): November 16, 2012

Study Record Updates

• Last Update Posted (Actual): March 5, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Hemodialysis and AV fistula
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 11-08-302