Anesthetic Technique for AV Fistulae Creation
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 4/17/2018 |
| Start Date: | February 2012 |
| End Date: | July 15, 2016 |
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 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).
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).
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,
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Naum Shaparin, MD
Phone: 718-920-5932
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Click here to add this to my saved trials
