Paravertebral Block With Brachial Plexus Block for Upper Arm Arteriovenous Fistula Surgery

The Effectiveness of Thoracic Paravertebral Block in Improving the Anesthetic Effects of Regional Anesthesia for Upper Extremity Arteriovenous Fistula Surgery

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.

Study Overview

• Status: Completed
• Conditions: Regional Anesthesia Success
• Intervention / Treatment: Procedure: Subcutaneous infiltration of intercostobrachial nerve; Procedure: T2 paravertebral nerve block

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intercostobrachial nerve Infiltration; Preoperative infiltration of intercostobrachial nerve with 10ml of ropivacaine 0.5%	Procedure: Subcutaneous infiltration of intercostobrachial nerve; Preoperative subcutaneous infiltration of intercostobrachial nerve with 10ml of 0.5% ropivacaine
Active Comparator: Ultrasound guided T2 paravertebral block; Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of ropivacaine 0.5%	Procedure: T2 paravertebral nerve block; Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of 0.5% ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Stuart A Grant, UNC Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 20-2303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: Approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No