drugset / Trial / NCT07216820

Interscalene vs Phrenic-sparing Blocks in Obesity and Effect of Maximum Inspiratory Pressure

NCT07216820 ↗

RandomizedParallel-groupSingle-blindTreatment

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-strength test (maximum inspiratory pressure, MIP) helps identify who is at higher risk. The main questions are: Does the phrenic-sparing approach reduce breathlessness or oxygen need in the recovery room (30-60 minutes after arrival)? Do patients have similar pain control and opioid use compared with the standard interscalene block (ISB)? Are there any breathing-related complications or unplanned admissions within 24 hours? Researchers will compare the phrenic-sparing block (infraclavicular + distal suprascapular) to the standard ISB, both commonly used at UNC. Participants will: Have a quick MIP breath test before surgery (and, if age ≥65, a brief thigh muscle ultrasound). Be randomly assigned to receive either the standard ISB or the phrenic-sparing block (both ultrasound-guided and part of routine care). Receive usual anesthesia/surgery; have a brief recovery check at 30-60 minutes (breathlessness score, oxygen use, oxygen level). Have pain medicines recorded from anesthesia start to PACU discharge; the team may review the chart up to 24 hours and make a short follow-up call (24-48 hours).

Timeline

Start
2026-01-21
Primary completion
2027-11-01
Completion
2027-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 75 mg Other
Subject Bupivacaine Other / unclassified 135 mg Other
Subject Dexamethasone Small molecule 4 mg Other
Subject Dexamethasone Small molecule 8 mg Other

Indications