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CompletedNCT06549244Updated Aug 12, 2024

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

An observational study in Dyspnea After Interscalene Nerve Block, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by University of North Carolina, Chapel Hill · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Dyspnea After Interscalene Nerve Block

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03

In context

Dyspnea

656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's enrollment of 45 is below the median of 122 across 204 observational studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients presenting for shoulder surgery with preoperative interscalene block (Groups 1 and 2). Group 3 includes adult patients presenting for non thoracic, non abdominal surgery under general anesthesia.

Inclusion criteria

  • 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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • Block, Non-obese

    Non-obese, Body Mass Index (BMI)\<30, receiving interscalene block and general anesthesia for shoulder surgery

    Diagnostic Test: Maximum Inspiratory Pressure monitoring

  • Block, Obese

    Class 2 or higher Obese, BMI\>35, receiving interscalene block and general anesthesia for shoulder surgery

    Diagnostic Test: Maximum Inspiratory Pressure monitoring

  • Control

    control group, included non-shoulder surgery patients receiving general anesthesia only

    Diagnostic Test: Maximum Inspiratory Pressure monitoring

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

    Also known as: Spirometry measurements, Modified Borg breathlessness questionnaire

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What researchers measure

Primary outcomes

  1. Incidence of Moderate to Severe Breathlessness

    Score of 3 or above on Modified Borg Breathlessness Scale

    Time frame: Baseline (Arrival to pre-operative phase), Recovery (Immediately post-surgical, up to 3 hours)

Secondary outcomes

  1. Oxygen Saturation in post-anesthesia care unit

    Measured by pulse oximetry

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

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

    Total time spent in post-operative phase of care

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

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

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

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

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Study locations

1 site
  • University of North Carolina
    Chapel Hill, North Carolina 27599, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06549244
Lead sponsor
University of North Carolina, Chapel Hill
Responsible party
Sponsor
First posted
Aug 12, 2024
Start date
Jul 1, 2023
Primary completion
Nov 28, 2023
Completion
Jan 10, 2024
Last update
Aug 12, 2024

Study contacts

Monika Nanda
principal investigator · University of North Carolina

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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