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
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Mason Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Benaroya Research Institute |
United States,
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 |
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