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

A Pilot Study on Inspiratory Dynamics and the Effect of Body Mass Index on Respiratory Outcomes After Temporary Hemi Diaphragmatic Paresis Related to Brachial Plexus Blocks

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06549244
Enrollment
45
Registered
2024-08-12
Start date
2023-07-01
Completion date
2024-01-10
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea After Interscalene Nerve Block

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.

Interventions

DIAGNOSTIC_TESTMaximum Inspiratory Pressure monitoring

Lung volumes, pressures and breathlessness scores to be measured in pre and post operative phase of care on the same day

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Groups 1 and 2 * Adults \>18 years of age receiving shoulder surgery with preoperative interscalene block and general anesthesia; * Speak English; Group 3 · Adults \>18 years of age receiving cystoscopy or lower extremity procedures receiving general endotracheal anesthesia

Exclusion criteria

All Groups * Less than 18 years of age; * currently pregnant; * currently incarcerated; * those with significant neuromuscular disease, tracheo-bronchial structural abnormalities, severe respiratory or severe cardiovascular comorbidity; * those undergoing intra-abdominal or intrathoracic surgeries due to the potential to independently effect breathing

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Oxygen Saturation in post-anesthesia care unitRecovery (Immediately post-surgical, up to 3 hours)Measured by pulse oximetry
Post-anesthesia care unit length-of-stayRecovery (Immediately post-surgical, up to 3 hours)Total time spent in post-operative phase of care
Duration of Oxygen supplementation in post-anesthesia care unitRecovery (Immediately post-surgical, up to 3 hours)Total duration of oxygen supplementation in post-operative phase of care

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026