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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Dose of 0.5% Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: David Auyong; Phone Number: 206-223-6980; Email: anedba@vmmc.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Virginia Mason Medical Center
      • Contact: David B Auyong, MD; Phone Number: 206-223-6980; Email: David.Auyong@virginiamason.org
      • Sub-Investigator: David B Auyong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brachial Plexus Block Group 1; Interscalene	Drug: Dose of 0.5% Ropivacaine; Dose varied by 5mL of 0.5% Ropivacaine
Experimental: Brachial Plexus Group 2; Supraclavicular	Drug: Dose of 0.5% Ropivacaine; Dose varied by 5mL of 0.5% Ropivacaine
Experimental: Brachial Plexus Group 3; Suprascapular	Drug: Dose of 0.5% Ropivacaine; Dose varied by 5mL of 0.5% Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragm Excursion	Change in Movement of Diaphragm in cm	60 minutes after surgery
Vital Capacity	Change in Vital Capacity measured in L	60 minutes after surgery
Pulse Oximetry	Change in Pulse Oximetry Value	60 minutes after surgery
Side Effects	Rate of Dyspnea, Horner's, Hoarseness	60 minutes after surgery

Collaborators and Investigators

• Sponsor: Benaroya Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: brachial plexus block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: IRB20-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No