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Compares treatment options for Shoulder Surgery
Official title Interscalene vs Phrenic-sparing Blocks in Obesity and Effect of Maximum Inspiratory Pressure
ClinicalTrials.gov ID: NCT07216820
What this study is testing
What is Bupivacaine HCl 0.5% Injectable Solution?
Bupivacaine HCl 0.5% Injectable Solution is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for shoulder surgery.
Also referred to as Bupivacaine Hydrochloride Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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...
- 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 \ 1.5) or local infection at block sites (pre-op labs/assessment).
See the full eligibility 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).
- 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 \ 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.