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

NCT04720079 | Completed

• 1 other identifier: 20-2303
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia Success

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intercostobrachial nerve Infiltration

ACTIVE COMPARATOR

Preoperative infiltration of intercostobrachial nerve with 10ml of ropivacaine 0.5%

Procedure: Subcutaneous infiltration of intercostobrachial nerve

Ultrasound guided T2 paravertebral block

ACTIVE COMPARATOR

Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of ropivacaine 0.5%

Procedure: T2 paravertebral nerve block

Interventions

Subcutaneous infiltration of intercostobrachial nerve PROCEDURE

Preoperative subcutaneous infiltration of intercostobrachial nerve with 10ml of 0.5% ropivacaine

Intercostobrachial nerve Infiltration

T2 paravertebral nerve block PROCEDURE

Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of 0.5% ropivacaine

Ultrasound guided T2 paravertebral block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years) undergoing upper limb arteriovenous fistula surgery at UNC Chapel Hill hospital

You may not qualify if:

• Contraindication to regional anesthesia
• Significant peripheral neuropathy or neurological disorder of the upper extremity
• Cognitive or psychiatric condition that will interfere with patient assessment

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Stuart A Grant

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: November 15, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: May 13, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 9 to 36 months following publication
• Access Criteria: Approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC

Locations

US (1)