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NCT07216820 · ClinicalTrials.gov registry record · NA
Interscalene vs Phrenic-sparing Blocks in Obesity and Effect of Maximum Inspiratory Pressure
A NA study of Obesity and Shoulder Surgery, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT07216820: Recruiting NA study of Obesity and Shoulder Surgery, sponsored by University of North Carolina, Chapel Hill.
NCT07216820 is a NA study of Obesity and Shoulder Surgery that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 68 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07216820, a NA study of Obesity and Shoulder Surgery, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Ultrasound-Guided Interscalene Brachial Plexus Block
- PROCEDURE Phrenic-Sparing Block Combination (Experimental)
- DRUG Bupivacaine HCl 0.5% Injectable Solution
- DRUG Dexamethasone 4mg
Study Locations (1)
North Carolina
- University of North Carolina Hospitals - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2026-01-21 |
| Est. Completion | 2027-11-15 |
| Phase | NA |
What NCT07216820 shows while recruiting
NCT07216820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 4 interventions - of which Ultrasound-Guided Interscalene Brachial Plexus Block is the first listed.
NCT07216820 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT07216820 about?
NCT07216820 is a clinical study titled "Interscalene vs Phrenic-sparing Blocks in Obesity and Effect of Maximum Inspiratory Pressure". 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 question...
What is the current status of trial NCT07216820?
This trial is currently recruiting. It is a NA study. The enrollment target is 68 participants. The study started on 2026-01-21. Estimated completion is 2027-11-15.
What conditions does trial NCT07216820 study?
This clinical trial studies the following conditions: Obesity, Shoulder Surgery.
What interventions are being tested in trial NCT07216820?
The interventions under investigation include: Ultrasound-Guided Interscalene Brachial Plexus Block (PROCEDURE), Phrenic-Sparing Block Combination (Experimental) (PROCEDURE), Bupivacaine HCl 0.5% Injectable Solution (DRUG), Dexamethasone 4mg (DRUG).
Who is sponsoring clinical trial NCT07216820?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07216820 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07216820's enrollment target sits among peer trials
68 611th of 1053 higher than 439 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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