## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 20-2303
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
### Status Module
#### Completion Date
**Date:** 2022-02-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-05-13

**Type:** ACTUAL

**Last Update Submit Date:** 2022-05-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-02-15

**Type:** ACTUAL

#### Start Date
**Date:** 2020-11-15

**Type:** ACTUAL

**Status Verified Date:** 2021-11

#### Study First Post Date
**Date:** 2021-01-22
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-14
**Study First Submit QC Date:** 2021-01-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of North Carolina, Chapel Hill

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Regional Anesthesia Success

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 63

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Preoperative infiltration of intercostobrachial nerve with 10ml of ropivacaine 0.5%

**Intervention Names:**

- Procedure: Subcutaneous infiltration of intercostobrachial nerve

**Label:** Intercostobrachial nerve Infiltration

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Procedure: T2 paravertebral nerve block

**Label:** Ultrasound guided T2 paravertebral block

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intercostobrachial nerve Infiltration

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

**Name:** Subcutaneous infiltration of intercostobrachial nerve

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Ultrasound guided T2 paravertebral block

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

**Name:** T2 paravertebral nerve block

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Success is considered a regional anesthetic without rescue analgesic medications (including surgeon administered local anesthetic) or conversion to general anesthesia

**Measure:** Number of Participants with Successful Regional Anesthesia

**Time Frame:** By end of surgery

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chapel Hill

**Country:** United States

**Facility:** University of North Carolina at Chapel Hill

**State:** North Carolina

**Zip:** 27599

#### Overall Officials

**Official 1:**

**Affiliation:** UNC Chapel Hill

**Name:** Stuart A Grant

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC

**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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** 9 to 36 months following publication

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000001165

- Term: Arteriovenous Malformations

- ID: D000054079

- Term: Vascular Malformations

- ID: D000018376

- Term: Cardiovascular Abnormalities

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016157

- Term: Vascular Fistula

- ID: D000014652

- Term: Vascular Diseases

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M8532

- Name: Fistula

- Relevance: HIGH

- As Found: Fistula

- ID: M4472

- Name: Arteriovenous Fistula

- Relevance: HIGH

- As Found: Arteriovenous Fistula

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M4473

- Name: Arteriovenous Malformations

- Relevance: LOW

- As Found: Unknown

- ID: M27558

- Name: Vascular Malformations

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M18619

- Name: Vascular Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001164

- Term: Arteriovenous Fistula

- ID: D000005402

- Term: Fistula

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1700

- Name: Ropivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
