Status:
NOT_YET_RECRUITING
Interscalene vs Phrenic-sparing Blocks in Obesity and Effect of Maximum Inspiratory Pressure
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
American Society of Regional Anesthesia
Conditions:
Shoulder Surgery
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn whether a phrenic-sparing nerve block can lower early breathing problems after shoulder surgery in adults with obesity, and whether a simple breathing-stren...
Eligibility Criteria
Inclusion
- Age ≥ 18 years (self-report, confirmed on chart).
- Body-mass index ≥ 35 kg m\^2 at the pre-operative clinic visit (chart).
- Scheduled for elective unilateral shoulder surgery (arthroscopy, arthroplasty, rotator cuff repair, reverse arthroplasty) under general anesthesia at UNC Hospitals
- Planned use of a single-injection regional brachial-plexus block for postoperative analgesia (anesthesia record).
- Able to perform a maximal-inspiratory-pressure (MIP) maneuver at screening, producing two reproducible efforts (bedside test)
- Able to read or understand English and provide written informed consent (consent discussion).
Exclusion
- Emergent or trauma shoulder procedure or case converted to open surgery (schedule/chart).
- Pregnancy confirmed by point-of-care urine test on day of surgery (POC test). Prisoner status or legal incapacity to consent (chart/interview).
- Severe pulmonary disease: GOLD stage 3-4 COPD, restrictive lung disease unrelated to obesity with FVC \< 50 % predicted, baseline dyspnea Borg ≥ 3, or home oxygen therapy (pulmonary clinic notes, patient interview).
- Severe heart disease- Severe valvular heart disease, Congestive Heart Failure NYHA Class III or IV, Obstructive Coronary Artery Disease with Angina
- Neuromuscular disorders affecting respiratory muscles (e.g., ALS, myasthenia gravis) or known diaphragmatic paralysis (chart).
- Coagulopathy (platelets \< 100 × 10/ L or INR \> 1.5) or local infection at block sites (pre-op labs/assessment).
- Anemia and hemoglobinopathies: Hgb \<10 g/dl, clinically significant hemoglobinopathy.
- Allergy to bupivacaine, dexamethasone, or ultrasound gel (self-report).
- Chronic opioid use \> 100 mg oral-morphine equivalents per day in the three months preceding surgery (medication history, PDMP query).
- Prior enrolment in this trial or planned participation in another interventional study that might confound outcomes (research registry).
- Anticipated inability to comply with postoperative assessments (e.g., profound cognitive impairment, expected early transfer to outside facility) as judged by the investigator
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2027
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT07216820
Start Date
November 1 2025
End Date
November 15 2027
Last Update
October 20 2025
Active Locations (1)
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1
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599