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OpenTrials
Completed

NCT Number: NCT06549244

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

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.

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Key information

Conditions

Dyspnea After Interscalene Nerve Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maximum Inspiratory Pressure monitoring

Diagnostic Test

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

Other names: Spirometry measurements, Modified Borg breathlessness questionnaire

Primary outcomes

  1. Incidence of Moderate to Severe Breathlessness

    Time frame: 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 outcomes

  1. Oxygen Saturation in post-anesthesia care unit

    Time frame: Recovery (Immediately post-surgical, up to 3 hours)

    Measured by pulse oximetry

  2. Post-anesthesia care unit length-of-stay

    Time frame: Recovery (Immediately post-surgical, up to 3 hours)

    Total time spent in post-operative phase of care

  3. Duration of Oxygen supplementation in post-anesthesia care unit

    Time frame: Recovery (Immediately post-surgical, up to 3 hours)

    Total duration of oxygen supplementation in post-operative phase of care

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.