Anesthetic Technique for AV Fistulae Creation

End Stage Renal Failure on Dialysis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01727557
• Other study ID #: 11-08-302
• Status: Terminated
• Phase: N/A
• First received: June 8, 2012
• Last updated: March 1, 2018
• Start date: February 2012
• Est. completion date: July 15, 2016

Study information

• Verified date: March 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 15, 2016
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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,

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Procedure:
• regional anesthesia
Regional anesthesia will be compared to local anesthesia
• local anesthesia
Regional anesthesia will be compared to local anesthesia

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three months from the day of creation
Secondary	Short term comfort level	To assess patient comfort level after creation of AV fistula (e.g. nausea, analgesia).	Within three days of procedure
Secondary	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.	Three days after the creation