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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
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)
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)
Infraclavicular: Adminstered as 15 mL (75 mg) injection (together with dexamethasone). Distal Suprascapular: Adminstered as 12 mL (60 mg) injection (together with dexamethasone).
Adminstered as applicable for infraclavicular and distal suprascapular: as 1 mL (4 mg) injection (together with bupicacaine 0.5%).
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
RECRUITINGIncidence of Early Postoperative Respiratory Compromise
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.
Time frame: Within 60 minutes after arrival to PACU
Effect Modification by Preoperative Maximum Inspiratory Pressure (MIP)
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).
Time frame: Baseline (preoperative MIP test) and PACU assessment (30-60 minutes post-surgery).
Lowest Oxygen Saturation (SpO₂) in PACU
Minimum oxygen saturation recorded by pulse oximetry during the PACU stay Unit of Measure: Percent (%)
Time frame: From PACU arrival to discharge (typically 60-120 minutes)
Total Duration of Supplemental Oxygen Use
Total number of hours on oxygen from PACU arrival until hospital discharge (maximum 24 hours). Unit of Measure: Hours.
Time frame: 0-24 hours post-surgery.
Post-Induction Opioid Consumption
Total opioid dose administered from anesthesia induction to PACU discharge, converted to oral morphine milligram equivalents (OMME). Unit of Measure: mg OMME.
Time frame: 0-6 hours post-surgery.
Diaphragmatic Excursion Change from Baseline
Percent change in diaphragmatic excursion (ultrasound-measured) from baseline to PACU. Unit of Measure: Percent change (%).
Time frame: Baseline (pre-block) and 30-60 minutes post-surgery in PACU.
PACU Pain Score
Numeric Rating Scale (NRS) for pain recorded at 30-60 minutes post-surgery. Unit of Measure: 0-10 NRS scale.
Time frame: Within 1 hour after PACU arrival.
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