Anesthetic Technique for AV Fistulae Creation

NCT ID: NCT01727557

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-07-15

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).

Conditions

End Stage Renal Failure on Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Local anesthesia

Group Type: ACTIVE_COMPARATOR

regional anesthesia

Intervention Type: PROCEDURE

Regional anesthesia will be compared to local anesthesia

regional anesthesia

Group Type: ACTIVE_COMPARATOR

local anesthesia

Intervention Type: PROCEDURE

Regional anesthesia will be compared to local anesthesia

Interventions

regional anesthesia

Regional anesthesia will be compared to local anesthesia

Intervention Type: PROCEDURE

local anesthesia

Regional anesthesia will be compared to local anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

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,

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Naum Shaparin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

11-08-302

Identifier Type: -

Identifier Source: org_study_id