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

NCT ID: NCT05868993

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-17

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Brachial Plexus Block Group 1

Interscalene

Group Type EXPERIMENTAL

Dose of 0.5% Ropivacaine

Intervention Type DRUG

Dose varied by 5mL of 0.5% Ropivacaine

Brachial Plexus Group 2

Supraclavicular

Group Type EXPERIMENTAL

Dose of 0.5% Ropivacaine

Intervention Type DRUG

Dose varied by 5mL of 0.5% Ropivacaine

Brachial Plexus Group 3

Suprascapular

Group Type EXPERIMENTAL

Dose of 0.5% Ropivacaine

Intervention Type DRUG

Dose varied by 5mL of 0.5% Ropivacaine

Interventions

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Dose of 0.5% Ropivacaine

Dose varied by 5mL of 0.5% Ropivacaine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benaroya Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Virginia Mason Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David Auyong

Role: CONTACT

206-223-6980

Facility Contacts

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David B Auyong, MD

Role: primary

206-223-6980

Other Identifiers

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IRB20-018

Identifier Type: -

Identifier Source: org_study_id

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