NCT05868993

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 22, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

April 27, 2023

Last Update Submit

May 11, 2023

Conditions

Post Operative Pain

Keywords

brachial plexus block

Outcome Measures

Primary Outcomes (3)

  • Block Success

    Block success measured by pain (11-point VAS)

    60min after surgery

  • Lung Function

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

    60 mins after surgery

  • Block Success

    Block Success measured by opioid (mcg of fentanyl delivered)

    60 mins after surgery

Secondary Outcomes (4)

  • Diaphragm Excursion

    60 minutes after surgery

  • Vital Capacity

    60 minutes after surgery

  • Pulse Oximetry

    60 minutes after surgery

  • Side Effects

    60 minutes after surgery

Study Arms (3)

Brachial Plexus Block Group 1

EXPERIMENTAL

Interscalene

Drug: Dose of 0.5% Ropivacaine

Brachial Plexus Group 2

EXPERIMENTAL

Supraclavicular

Drug: Dose of 0.5% Ropivacaine

Brachial Plexus Group 3

EXPERIMENTAL

Suprascapular

Drug: Dose of 0.5% Ropivacaine

Interventions

Dose of 0.5% RopivacaineDRUG

Dose varied by 5mL of 0.5% Ropivacaine

Brachial Plexus Block Group 1Brachial Plexus Group 2Brachial Plexus Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgical candidate for Arthroscopic rotator cuff surgery
  • ASA I-III
  • BMI\<40
  • Age \>18

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

David Auyong

CONTACT

206-223-6980anedba@vmmc.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 22, 2023

Study Start

February 17, 2023

Primary Completion

February 1, 2025

Study Completion

December 1, 2025

Last Updated

May 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)