Extended Regional Block following Arteriovenous Fistula Creation

Overview

About this study

This pilot study will be conducted at Mayo Clinic (Jacksonville) in 10 subjects.  The primary focus of this study will be to assess the pain control following surgery with the utilization of ambit electronic pump through visual analogue scale (VAS), numeric rating scale (NRS), verbal rating scale (VRS), we will assess the fistula over the first few hours and days following the AVF procedure to study the patency of the arteriovenous fistula.

Post-procedure, the patient will receive the pump and instructions for use.  The pump will be used to deliver 0.2% ropivacaine over the indicated 5-day period post-surgery.  Five days was chosen based on the product’s FDA approved indication.  A continuous infusion of 5 cc per hour of 0.2% ropivacaine will be initiated in the recovery room and discontinued on postoperative day 5.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥18 years of age, need for hemodialysis

Exclusion Criteria:

  • Previous fistulas, central vein occlusion, ipsilateral upper extremity deep vein occlusion, ipsilateral brachial or radial artery stenosis or calcification, coagulopathy, and/or infection at the operative site

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/11/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Houssam Farres, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available
.
CLS-20570072

Mayo Clinic Footer