Anesthetic Technique for AV Fistulae Creation

NCT01727557 | Terminated

• 1 other identifier: 11-08-302
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Failure on Dialysis

Keywords

Hemodialysis and AV fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Short term comfort level

  Within three days of procedure

• Short term safety, number of post operative complications

  Three days after the creation

Study Arms (2)

Local anesthesia

ACTIVE COMPARATOR

Procedure: regional anesthesia

regional anesthesia

ACTIVE COMPARATOR

Procedure: local anesthesia

Interventions

regional anesthesia PROCEDURE

Regional anesthesia will be compared to local anesthesia

Local anesthesia

local anesthesia PROCEDURE

Regional anesthesia will be compared to local anesthesia

regional anesthesia

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Anesthesia, Conduction; Anesthesia, Local

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: November 16, 2012
• Study Start: February 1, 2012
• Primary Completion: July 15, 2016
• Study Completion: July 15, 2016
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

US (1)