Dyspnea After Interscalene Nerve BlockNCT06549244
Preoperative Maximum Inspiratory Pressure and Outcomes After Interscalene Block in Obese Patients
An observational study of Dyspnea After Interscalene Nerve Block, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea After Interscalene Nerve Block
- What is being tested?
- Maximum Inspiratory Pressure monitoring
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 10 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official 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
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.
- Conditions
- Dyspnea After Interscalene Nerve Block
- Being tested
- Maximum Inspiratory Pressure monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximum Inspiratory Pressure monitoringDiagnostic test
Also called Spirometry measurements, Modified Borg breathlessness questionnaire
Lung volumes, pressures and breathlessness scores to be measured in pre and post operative phase of care on the same day
| Study group | Role | What they receive |
|---|---|---|
| Block, Non-obese | Non-obese, Body Mass Index (BMI)<30, receiving interscalene block and general anesthesia for shoulder surgery Receives: Diagnostic Test: Maximum Inspiratory Pressure monitoring | |
| Block, Obese | Class 2 or higher Obese, BMI>35, receiving interscalene block and general anesthesia for shoulder surgery Receives: Diagnostic Test: Maximum Inspiratory Pressure monitoring | |
| Control | control group, included non-shoulder surgery patients receiving general anesthesia only Receives: Diagnostic Test: Maximum Inspiratory Pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Moderate to Severe Breathlessness
Score of 3 or above on Modified Borg Breathlessness Scale
Measured: Baseline (Arrival to pre-operative phase), Recovery (Immediately post-surgical, up to 3 hours)
Secondary outcomes (3)
Oxygen Saturation in post-anesthesia care unit
Measured by pulse oximetry
Measured: Recovery (Immediately post-surgical, up to 3 hours)
Post-anesthesia care unit length-of-stay
Total time spent in post-operative phase of care
Measured: Recovery (Immediately post-surgical, up to 3 hours)
Duration of Oxygen supplementation in post-anesthesia care unit
Total duration of oxygen supplementation in post-operative phase of care
Measured: Recovery (Immediately post-surgical, up to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Jul 2023
- Primary completion28 Nov 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyspnea After Interscalene Nerve BlockStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monika Nanda, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549244
- Sponsor's protocol ID
- 23-0924
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06549244
- Acronym / sponsor ID
- 23-0924
- Conditions
- Dyspnea After Interscalene Nerve Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Block, Non-obese | – | Diagnostic Test: Maximum Inspiratory Pressure monitoringNon-obese, Body Mass Index (BMI)<30, receiving interscalene block and general anesthesia for shoulder surgery |
| Block, Obese | – | Diagnostic Test: Maximum Inspiratory Pressure monitoringClass 2 or higher Obese, BMI>35, receiving interscalene block and general anesthesia for shoulder surgery |
| Control | – | Diagnostic Test: Maximum Inspiratory Pressure monitoringcontrol group, included non-shoulder surgery patients receiving general anesthesia only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximum Inspiratory Pressure monitoringAlso: Spirometry measurements, Modified Borg breathlessness questionnaireLung volumes, pressures and breathlessness scores to be measured in pre and post operative phase of care on the same day | Diagnostic test | Block, Non-obese, Block, Obese, Control |
Primary outcome
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
3 secondary outcomes
Oxygen Saturation in post-anesthesia care unit
Time frame: Recovery (Immediately post-surgical, up to 3 hours)
Post-anesthesia care unit length-of-stay
Time frame: Recovery (Immediately post-surgical, up to 3 hours)
Duration of Oxygen supplementation in post-anesthesia care unit
Time frame: Recovery (Immediately post-surgical, up to 3 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Nanda principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea After Interscalene Nerve Block, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Moderate to Severe Breathlessness (time frame: Baseline (Arrival to pre-operative phase), Recovery (Immediately post-surgical, up to 3 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.