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Preoperative Maximum Inspiratory Pressure and Outcomes After Interscalene Block in Obese Patients
N/A
Waitlist Available
Led By Monika Nanda
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recovery (immediately post-surgical, up to 3 hours)
Awards & highlights
No Placebo-Only Group
Summary
The study aims to explore if Maximum Inspiratory Pressure can predict postoperative breathlessness in obese patients receiving interscalene blocks for shoulder surgery. The main question is: does baseline Maximum Inspiratory Pressure have any association with postoperative breathlessness after interscalene blocks in class 2 or higher obese patients (BMI\>35). Preoperative and postoperative lung volumes, pressures, breathlessness score and respiratory outcomes will be measured on participants already receiving shoulder surgery with interscalene blocks.
Eligible Conditions
- Shoulder Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recovery (immediately post-surgical, up to 3 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recovery (immediately post-surgical, up to 3 hours)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Moderate to Severe Breathlessness
Secondary study objectives
Duration of Oxygen supplementation in post-anesthesia care unit
Oxygen Saturation in post-anesthesia care unit
Post-anesthesia care unit length-of-stay
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: ControlExperimental Treatment1 Intervention
control group, included non-shoulder surgery patients receiving general anesthesia only
Group II: Block, ObeseExperimental Treatment1 Intervention
Class 2 or higher Obese, BMI\>35, receiving interscalene block and general anesthesia for shoulder surgery
Group III: Block, Non-obeseExperimental Treatment1 Intervention
Non-obese, Body Mass Index (BMI)\<30, receiving interscalene block and general anesthesia for shoulder surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Maximum Inspiratory Pressure monitoring
2023
N/A
~50
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,662 Total Patients Enrolled
Monika NandaPrincipal InvestigatorUniversity of North Carolina