Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07216820

Recruiting nowNot applicableInterventional

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionShoulder Surgery, Obesity

Full registry criteria

Inclusion Criteria: * 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). Exclusion Criteria: * 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 * Neuromuscular disorders affecting respiratory muscles (e.g., ALS, myasthenia gravis) or known diaphragmatic paralysis (chart). * Coagulopathy (platelets \< 100 × 10/ L or INR \> 1.5) or local infection at block sites (pre-op labs/assessment). * Anemia and hemoglobinopathies: Hgb \<10 g/dl, clinically significant hemoglobinopathy. * Allergy to bupivacaine, dexamethasone, or ultrasound gel (self-report). * Chronic opioid use \> 100 mg oral-morphine equivalents per day in the three months preceding surgery (medication history, PDMP query). * Prior enrolment in this trial or planned participation in another interventional study that might confound outcomes (research registry). * Anticipated inability to comply with postoperative assessments (e.g., profound cognitive impairment, expected early transfer to outside facility) as judged by the investigator

Treatments and study arms

Ultrasound-Guided Interscalene Brachial Plexus Block

Procedure

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)

Procedure

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

Drug

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

Drug

Adminstered as applicable for infraclavicular and distal suprascapular: as 1 mL (4 mg) injection (together with bupicacaine 0.5%).

Primary outcomes

Incidence of Early Postoperative Respiratory CompromiseWithin 60 minutes after arrival to PACU

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.

Effect Modification by Preoperative Maximum Inspiratory Pressure (MIP)Baseline (preoperative MIP test) and PACU assessment (30-60 minutes post-surgery).

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.

University of North Carolina Hospitals🇺🇸 Chapel Hill, North Carolina, United States
Monika NandaContact