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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04720079
Other study ID # 20-2303
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2020
Est. completion date February 15, 2022

Study information

Verified date November 2021
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary goal of this quality improvement project is to find the optimal surgical conditions for patients undergoing upper arm arteriovenous graft surgery. Currently, there are two anesthetic techniques used in clinical practice. The goal is to standardize future practice and improve the care of patients postoperatively. The two techniques used in conjunction with a brachial plexus block are paravertebral nerve block and subcutaneous infiltration.


Description:

This study is designed to test the null hypothesis that paravertebral nerve block or subcutaneous infiltration provide similar operating conditions when combined with supraclavicular nerve block for upper arm arteriovenous fistula surgery. The results will help determine which approach to use and guide future research in this area.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date February 15, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (>18 years) undergoing upper limb arteriovenous fistula surgery at UNC Chapel Hill hospital Exclusion Criteria: - Contraindication to regional anesthesia - Significant peripheral neuropathy or neurological disorder of the upper extremity - Cognitive or psychiatric condition that will interfere with patient assessment

Study Design


Intervention

Procedure:
Subcutaneous infiltration of intercostobrachial nerve
Preoperative subcutaneous infiltration of intercostobrachial nerve with 10ml of 0.5% ropivacaine
T2 paravertebral nerve block
Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of 0.5% ropivacaine

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Successful Regional Anesthesia Success is considered a regional anesthetic without rescue analgesic medications (including surgeon administered local anesthetic) or conversion to general anesthesia By end of surgery