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.
Brief Title
Anesthetic Technique for AV Fistulae Creation
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).
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
End Stage Renal Failure on Dialysis
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,
* 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,
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Hemodialysis and AV fistula
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
21 Years
NCT Id
NCT01727557
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
11-08-302
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Primary Outcomes
Outcome 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.
Outcome Measure
AV fistula success rate
Outcome Time Frame
Three months from the day of creation
Secondary Outcomes
Outcome Description
To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).
Outcome Time Frame
Within three days of procedure
Outcome Measure
Short term comfort level
Outcome Description
b) To evaluate the immediate complications (within 3 days)after AV fistula construction under regional anesthesia or local anesthesia.
Outcome Time Frame
Three days after the creation
Outcome Measure
Short term safety, number of post operative complications
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Naum Shaparin
Investigator Email
nshapari@montefiore.org
Investigator Phone