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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05868993
Enrollment
150
Registered
2023-05-22
Start date
2023-02-17
Completion date
2025-12-31
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Keywords

brachial plexus block

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.

Interventions

DRUGDose of 0.5% Ropivacaine

Dose varied by 5mL of 0.5% Ropivacaine

Sponsors

Benaroya Research Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Block Success60min after surgeryBlock success measured by pain (11-point VAS)
Lung Function60 mins after surgeryBlock success as measured by preservation of lung function (Vital Capacity in L)

Secondary

MeasureTime frameDescription
Diaphragm Excursion60 minutes after surgeryChange in Movement of Diaphragm in cm
Vital Capacity60 minutes after surgeryChange in Vital Capacity measured in L
Pulse Oximetry60 minutes after surgeryChange in Pulse Oximetry Value
Side Effects60 minutes after surgeryRate of Dyspnea, Horner's, Hoarseness

Countries

United States

Contacts

Primary ContactDavid Auyong
anedba@vmmc.org206-223-6980

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026