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Interscalene vs Phrenic-sparing Blocks in Obesity: Effect of Pre-operative Maximum Inspiratory Pressure in a Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
North Carolina
University of North Carolina Hospitals
RECRUITING
Chapel Hill
Contact Information
Primary
Monika Nanda
mnanda@aims.unc.edu
919-966-5136
Time Frame
Start Date: 2026-01-21
Estimated Completion Date: 2027-11-15
Participants
Target number of participants: 68
Treatments
Active_comparator: Arm 1: Standard Interscalene Block
Standard Interscalene Brachial Plexus Block (Control)~Description:~Participants receive a single 16 mL interscalene block at the C5-C6 level under ultrasound guidance. The injectate contains 15 mL of 0.5% bupivacaine HCl (75 mg) mixed with 1 mL preservative-free dexamethasone (4 mg).
Experimental: Arm 2: Phrenic-Sparing Block Combination
Combined Infraclavicular + Distal Suprascapular Block (Phrenic-Sparing Technique)~Description:~Participants receive two ultrasound-guided peripheral nerve blocks designed to minimize phrenic nerve involvement:~Infraclavicular block: 15 mL 0.5% bupivacaine + 1 mL dexamethasone (total 16 mL) Distal suprascapular block: 12 mL 0.5% bupivacaine + 1 mL dexamethasone (total 13 mL) Total local-anesthetic dose = 135 mg bupivacaine + 8 mg dexamethasone, within accepted safety limits.
Related Therapeutic Areas
Sponsors
Leads: University of North Carolina, Chapel Hill
Collaborators: American Society of Regional Anesthesia

This content was sourced from clinicaltrials.gov