Preoperative Maximum Inspiratory Pressure and Outcomes After Interscalene Block in Obese Patients

Completed

• Conditions: Dyspnea After Interscalene Nerve Block
• Interventions: Diagnostic Test: Maximum Inspiratory Pressure monitoring

• Registration Number: NCT06549244
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-11-28
• Study Completion: 2024-01-10
• Status Verified: 2024-07
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Block, Non-obese	Maximum Inspiratory Pressure monitoring	Non-obese, Body Mass Index (BMI)\<30, receiving interscalene block and general anesthesia for shoulder surgery
Block, Obese	Maximum Inspiratory Pressure monitoring	Class 2 or higher Obese, BMI\>35, receiving interscalene block and general anesthesia for shoulder surgery
Control	Maximum Inspiratory Pressure monitoring	control group, included non-shoulder surgery patients receiving general anesthesia only

Primary Outcome Measures

Name	Time	Method
Incidence of Moderate to Severe Breathlessness	Baseline (Arrival to pre-operative phase), Recovery (Immediately post-surgical, up to 3 hours)	Score of 3 or above on Modified Borg Breathlessness Scale

Secondary Outcome Measures

Name	Time	Method
Oxygen Saturation in post-anesthesia care unit	Recovery (Immediately post-surgical, up to 3 hours)	Measured by pulse oximetry
Duration of Oxygen supplementation in post-anesthesia care unit	Recovery (Immediately post-surgical, up to 3 hours)	Total duration of oxygen supplementation in post-operative phase of care
Post-anesthesia care unit length-of-stay	Recovery (Immediately post-surgical, up to 3 hours)	Total time spent in post-operative phase of care

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States