Clinical trial
Interscalene vs Phrenic-sparing Blocks in Obesity and Effect of Maximum Inspiratory Pressure
Recruiting now · Not applicable · 1 countries · Registry ID NCT07216820
What this study is about
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).
Basic eligibility
Full registry criteria
Treatments and study arms
Ultrasound-Guided Interscalene Brachial Plexus Block
Single 16 mL injection (15 mL 0.5 % bupivacaine + 1 mL dexamethasone 4 mg) at the C5-C6 root level under ultrasound guidance. Performed pre-operatively as standard care for shoulder surgery. Arm Cross-Reference: Standard Interscalene Block (Control)
Phrenic-Sparing Block Combination (Experimental)
Infraclavicular: 15 mL (75 mg) 0.5 % bupivacaine + 1 mL dexamethasone (4 mg) injected around the cords of the brachial plexus beneath the clavicle under ultrasound guidance. Distal Suprascapular: 12 mL (60 mg) 0.5 % bupivacaine + 1 mL (4 mg) dexamethasone injected at the suprascapular notch under ultrasound guidance to provide complete shoulder coverage while minimizing phrenic nerve involvement. Total local anesthetic dose = 135 mg bupivacaine + 8 mg dexamethasone. Arm Cross-Reference: Phrenic-Sparing Block Combination (Experimental)
Bupivacaine HCl 0.5% Injectable Solution
Infraclavicular: Adminstered as 15 mL (75 mg) injection (together with dexamethasone). Distal Suprascapular: Adminstered as 12 mL (60 mg) injection (together with dexamethasone).
Dexamethasone 4mg
Adminstered as applicable for infraclavicular and distal suprascapular: as 1 mL (4 mg) injection (together with bupicacaine 0.5%).
Primary outcomes
Composite outcome defined as either (a) a Modified Borg Dyspnea Score ≥ 3 in the post-anesthesia care unit (PACU, 30-60 minutes after surgery) or (b) continued need for supplemental oxygen at the PACU assessment. Outcome Type: Primary Unit of Measure: Percentage of participants meeting composite endpoint.
Assess whether the magnitude of treatment benefit from the phrenic-sparing block varies by baseline inspiratory-muscle strength. The effect is modeled as the interaction between block type and continuous MIP (cm H₂O) on the composite respiratory-compromise endpoint. Unit of Measure: Interaction odds ratio (per 10 cm H₂O decrement in MIP).
Study locations
1 locations were listed when this page was built. The first 40 are shown.