NCT07216820 Interscalene vs Phrenic-sparing Blocks in Obesity and Effect of Maximum Inspiratory Pressure
| NCT ID | NCT07216820 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Shoulder Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2026-01-21 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2026-01-21 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Monika Nanda
PRINCIPAL INVESTIGATOR
University of North Carollina at Chapel Hill
Frequently Asked Questions
Who can join the NCT07216820 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Shoulder Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07216820 currently recruiting?
Yes, NCT07216820 is actively recruiting participants. Contact the research team at mnanda@aims.unc.edu for enrollment information.
Where is the NCT07216820 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07216820 clinical trial?
NCT07216820 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Monika Nanda at University of North Carollina at Chapel Hill. The trial plans to enroll 68 participants.