Back to resultsParavertebral Block With Brachial Plexus Block for Upper Arm Arteriovenous Fistula Surgery
Primary Purpose
Regional Anesthesia Success
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Subcutaneous infiltration of intercostobrachial nerve
T2 paravertebral nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Regional Anesthesia Success
Eligibility Criteria
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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intercostobrachial nerve Infiltration
Ultrasound guided T2 paravertebral block
Arm Description
Preoperative infiltration of intercostobrachial nerve with 10ml of ropivacaine 0.5%
Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of ropivacaine 0.5%
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04720079
First Posted
January 14, 2021
Last Updated
May 11, 2022
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT04720079
Brief Title
Paravertebral Block With Brachial Plexus Block for Upper Arm Arteriovenous Fistula Surgery
Official Title
The Effectiveness of Thoracic Paravertebral Block in Improving the Anesthetic Effects of Regional Anesthesia for Upper Extremity Arteriovenous Fistula Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia Success
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intercostobrachial nerve Infiltration
Arm Type
Active Comparator
Arm Description
Preoperative infiltration of intercostobrachial nerve with 10ml of ropivacaine 0.5%
Arm Title
Ultrasound guided T2 paravertebral block
Arm Type
Active Comparator
Arm Description
Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of ropivacaine 0.5%
Intervention Type
Procedure
Intervention Name(s)
Subcutaneous infiltration of intercostobrachial nerve
Intervention Description
Preoperative subcutaneous infiltration of intercostobrachial nerve with 10ml of 0.5% ropivacaine
Intervention Type
Procedure
Intervention Name(s)
T2 paravertebral nerve block
Intervention Description
Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of 0.5% ropivacaine
Primary Outcome Measure Information:
Title
Number of Participants with Successful Regional Anesthesia
Description
Success is considered a regional anesthetic without rescue analgesic medications (including surgeon administered local anesthetic) or conversion to general anesthesia
Time Frame
By end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart A Grant
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Paravertebral Block With Brachial Plexus Block for Upper Arm Arteriovenous Fistula Surgery
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