End Stage Renal Failure on Dialysis
Conditions
Keywords
Hemodialysis and AV fistula
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: 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).
Interventions
PROCEDUREregional anesthesia
Regional anesthesia will be compared to local anesthesia
PROCEDURElocal anesthesia
Regional anesthesia will be compared to local anesthesia
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AV fistula success rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Short term comfort level | 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 | Three days after the creation | b) To evaluate the immediate complications (within 3 days)after AV fistula construction under regional anesthesia or local anesthesia. |
Countries
United States
Outcome results
None listed