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Anesthetic Technique for AV Fistulae Creation

Primary Purpose

End Stage Renal Failure on Dialysis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
regional anesthesia
local anesthesia
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Failure on Dialysis focused on measuring Hemodialysis and AV fistula

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Local anesthesia

regional anesthesia

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Short term comfort level
To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).
Short term safety, number of post operative complications
b) To evaluate the immediate complications (within 3 days)after AV fistula construction under regional anesthesia or local anesthesia.

Full Information

First Posted
June 8, 2012
Last Updated
March 1, 2018
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01727557
Brief Title
Anesthetic Technique for AV Fistulae Creation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Low Accural Rate
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 15, 2016 (Actual)
Study Completion Date
July 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure on Dialysis
Keywords
Hemodialysis and AV fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local anesthesia
Arm Type
Active Comparator
Arm Title
regional anesthesia
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
regional anesthesia
Intervention Description
Regional anesthesia will be compared to local anesthesia
Intervention Type
Procedure
Intervention Name(s)
local anesthesia
Intervention Description
Regional anesthesia will be compared to local anesthesia
Primary Outcome Measure Information:
Title
AV fistula success rate
Description
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.
Time Frame
Three months from the day of creation
Secondary Outcome Measure Information:
Title
Short term comfort level
Description
To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).
Time Frame
Within three days of procedure
Title
Short term safety, number of post operative complications
Description
b) To evaluate the immediate complications (within 3 days)after AV fistula construction under regional anesthesia or local anesthesia.
Time Frame
Three days after the creation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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,
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

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Anesthetic Technique for AV Fistulae Creation

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