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Anesthetic Technique for AV Fistulae Creation

This study is currently recruiting participants.
Verified November 2012 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
Naum Shaparin, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01727557
First received: June 8, 2012
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
End Stage Renal Failure on Dialysis
 Procedure: regional anesthesia
Procedure: local anesthesia
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • AV fistula success rate [ Time Frame: Three months from the day of creation ] [ Designated as safety issue: Yes ]
    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:
  • Short term comfort level [ Time Frame: Within three days of procedure ] [ Designated as safety issue: Yes ]
    To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).

  • Short term safety, number of post operative complications [ Time Frame: Three days after the creation ] [ Designated as safety issue: Yes ]
    b) To evaluate the immediate complications (within 3 days)after AV fistula construction under regional anesthesia or local anesthesia.


Estimated Enrollment: 175
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727557

Contacts
Contact: Singh Nair 718-920-5932 sinair@montefiore.org
Contact: Naum Shaparin, MD 718-920-8946 nshapari@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Singh Nair     718-920-5932     sinair@montefiore.org    
Principal Investigator: Naum Shaparin, MD            
Sponsors and Collaborators
Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Naum Shaparin, Assistant Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01727557     History of Changes
Other Study ID Numbers: AV Fistulae
Study First Received: June 8, 2012
Last Updated: November 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:
Hemodialysis and AV fistula

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013