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Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block

Primary Purpose

Post Operative Pain

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dose of 0.5% Ropivacaine

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring brachial plexus block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Surgical candidate for Arthroscopic rotator cuff surgery ASA I-III BMI<40 Age >18 Exclusion Criteria: Inability to give informed consent Inability to complete consent process in English allergy to ropivacaine neuropathy contraindications to peripheral nerve block per ASRA guidelines chronic opioid use infection at the injection/catheter site limb restriction due to medical history history of moderate - severe lung disease.

Sites / Locations

Virginia Mason Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Brachial Plexus Block Group 1

Brachial Plexus Group 2

Brachial Plexus Group 3

Arm Description

Interscalene

Supraclavicular

Suprascapular

Outcomes

Primary Outcome Measures

Block Success

Block success measured by pain (11-point VAS)

Lung Function

Block success as measured by preservation of lung function (Vital Capacity in L)

Block Success

Block Success measured by opioid (mcg of fentanyl delivered)

Secondary Outcome Measures

Diaphragm Excursion

Change in Movement of Diaphragm in cm

Vital Capacity

Change in Vital Capacity measured in L

Pulse Oximetry

Change in Pulse Oximetry Value

Side Effects

Rate of Dyspnea, Horner's, Hoarseness

Full Information

NCT ID

NCT05868993

First Posted

April 27, 2023

Last Updated

May 11, 2023

Sponsor

Benaroya Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05868993

Brief Title

Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block

Official Title

Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block Utilizing Continuous Reassessment Method for Arthroscopic Rotator Cuff Shoulder Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 17, 2023 (Actual)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Benaroya Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Prospective, patient-blinded study utilizing a novel Continuous Reassessment Method that concomitantly considers both block success and block side effects (lung dysfunction) for brachial plexus nerve blocks.

Detailed Description

Success or failure of the brachial plexus block for any given volume will be determined by the verbal analogue pain scale score obtained 60 minutes after surgical end time. Volumes will be determined by continuous reassessment method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain

Keywords

brachial plexus block

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Brachial Plexus Block Group 1

Arm Type

Experimental

Arm Description

Interscalene

Arm Title

Brachial Plexus Group 2

Arm Type

Experimental

Arm Description

Supraclavicular

Arm Title

Brachial Plexus Group 3

Arm Type

Experimental

Arm Description

Suprascapular

Intervention Type

Drug

Intervention Name(s)

Dose of 0.5% Ropivacaine

Intervention Description

Dose varied by 5mL of 0.5% Ropivacaine

Primary Outcome Measure Information:

Title

Block Success

Description

Block success measured by pain (11-point VAS)

Time Frame

60min after surgery

Title

Lung Function

Description

Block success as measured by preservation of lung function (Vital Capacity in L)

Time Frame

60 mins after surgery

Title

Block Success

Description

Block Success measured by opioid (mcg of fentanyl delivered)

Time Frame

60 mins after surgery

Secondary Outcome Measure Information:

Title

Diaphragm Excursion

Description

Change in Movement of Diaphragm in cm

Time Frame

60 minutes after surgery

Title

Vital Capacity

Description

Change in Vital Capacity measured in L

Time Frame

60 minutes after surgery

Title

Pulse Oximetry

Description

Change in Pulse Oximetry Value

Time Frame

60 minutes after surgery

Title

Side Effects

Description

Rate of Dyspnea, Horner's, Hoarseness

Time Frame

60 minutes after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Auyong

Phone

206-223-6980

anedba@vmmc.org

Facility Information:

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David B Auyong, MD

Phone

206-223-6980

David.Auyong@virginiamason.org

First Name & Middle Initial & Last Name & Degree

David B Auyong, MD

12. IPD Sharing Statement

Plan to Share IPD

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Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block

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