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Anesthetic Technique for AV Fistulae Creation

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ClinicalTrials.gov Identifier: NCT01727557
Recruitment Status : Terminated (Low Accural Rate)
First Posted : November 16, 2012
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Naum Shaparin, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Failure on Dialysis Procedure: regional anesthesia Procedure: local anesthesia Not Applicable

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  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2012
Actual Primary Completion Date : July 15, 2016
Actual Study Completion Date : July 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Fistulas
U.S. FDA Resources

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



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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727557


Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center

Responsible Party: Naum Shaparin, Assistant Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01727557     History of Changes
Other Study ID Numbers: 11-08-302
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Naum Shaparin, Montefiore Medical Center:
Hemodialysis and AV fistula

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