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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868993
• Other study ID #: IRB20-018
• Status: Recruiting
• Phase: Phase 4
• Start date: February 17, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: Benaroya Research Institute
• Contact: David Auyong
• Phone: 206-223-6980
• Email: anedba[@]vmmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Dose of 0.5% Ropivacaine
Dose varied by 5mL of 0.5% Ropivacaine

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Benaroya Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Block Success	Block success measured by pain (11-point VAS)	60min after surgery
Primary	Lung Function	Block success as measured by preservation of lung function (Vital Capacity in L)	60 mins after surgery
Primary	Block Success	Block Success measured by opioid (mcg of fentanyl delivered)	60 mins after surgery
Secondary	Diaphragm Excursion	Change in Movement of Diaphragm in cm	60 minutes after surgery
Secondary	Vital Capacity	Change in Vital Capacity measured in L	60 minutes after surgery
Secondary	Pulse Oximetry	Change in Pulse Oximetry Value	60 minutes after surgery
Secondary	Side Effects	Rate of Dyspnea, Horner's, Hoarseness	60 minutes after surgery