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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

June 8, 2012
November 16, 2012
March 5, 2018
February 2012
July 15, 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01727557 on ClinicalTrials.gov Archive Site
  • 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).
  • 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.
Same as current
Not Provided
Not Provided
 
Anesthetic Technique for AV Fistulae Creation
Not Provided
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.

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).

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
End Stage Renal Failure on Dialysis
  • Procedure: regional anesthesia
    Regional anesthesia will be compared to local anesthesia
  • Procedure: local anesthesia
    Regional anesthesia will be compared to local anesthesia
  • Active Comparator: Local anesthesia
    Intervention: Procedure: regional anesthesia
  • Active Comparator: regional anesthesia
    Intervention: Procedure: local anesthesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
175
July 15, 2016
July 15, 2016   (Final data collection date for primary outcome measure)

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,
Sexes Eligible for Study: All
21 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01727557
11-08-302
No
Not Provided
Not Provided
Naum Shaparin, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Not Provided
Montefiore Medical Center
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP