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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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 criteria

Qualifiers

Age ≥ 18 years (self-report, confirmed on chart).

Body-mass index ≥ 35 kg m² 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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ultrasound-Guided Interscalene Brachial Plexus Block
  • Phrenic-Sparing Block Combination (Experimental)
  • Bupivacaine HCl 0.5% Injectable Solution
  • Dexamethasone 4mg

Treatment groups

68 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

American Society of Regional Anesthesia

Collaborator