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

Phase 4

Recruiting

• Conditions: Post Operative Pain
• Interventions: Drug: Dose of 0.5% Ropivacaine

• Registration Number: NCT05868993
• Lead Sponsor: Benaroya Research Institute

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.

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-17
• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-05-11
• Last Update Submitted: 2023-05-11
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2025-02
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brachial Plexus Block Group 1	Dose of 0.5% Ropivacaine	Interscalene
Brachial Plexus Group 3	Dose of 0.5% Ropivacaine	Suprascapular
Brachial Plexus Group 2	Dose of 0.5% Ropivacaine	Supraclavicular

Primary Outcome Measures

Name	Time	Method
Block Success	60 mins after surgery	Block Success measured by opioid (mcg of fentanyl delivered)
Lung Function	60 mins after surgery	Block success as measured by preservation of lung function (Vital Capacity in L)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States