Phrenic Nerve ParalysisPhase 4NCT03636542
Evaluation of Diaphragm Movement After an Interscalene Block
A Phase 4 study testing liposomal bupivacaine and bupivacaine in people with Phrenic Nerve Paralysis, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phrenic Nerve Paralysis
- What is being tested?
- liposomal bupivacaine and bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 3 Jun 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- All patients age 18 years and older who are scheduled for shoulder surgery with interscalene block and remain in the hospital for more than 24 hours that are being randomized into a bupivacaine versus liposomal bupivacaine interscalene block study.
Who cannot join
- Non English speaking patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Minnesota
Minneapolis, Minnesota, 55455
About this study
The purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine. This study will evaluate if there is a possible prolonged phrenic nerve paralysis when using liposome bupivacaine in an interscalene block, using ultrasound.
Read the detailed description
This study will be run concurrently with two other studies comparing bupivacaine to Liposomal Bupivacaine in shoulder surgeries. We will use already randomized patients for our randomization process. For this study in particular we will use an ultrasound machine to scan the diaphragm of any patient who had an Interscalene Block for Total Shoulder Arthroplasy or Rotator Cuff Repair. Patients are to be scanned in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as an acoustic window. M Mode will be applied and the range of diaphragmatic movement from the resting expiratory position to deep inspiration (sigh test) will be recorded as was the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). The blocks will be done regardless of the study as they are standard of care for pain control. The only intervention is ultrasound examination of the patient's diaphragm at baseline, 3 hours post block in recovery room and on post-operative day 1, and basic spirometry to record FEV1 and FVC via a portable spirometer at the same time points. If patients did stay in hospital on postoperative day 2 we would also evaluate their diaphragm function.
- Conditions
- Phrenic Nerve Paralysis
- Being tested
- liposomal bupivacaine, bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal bupivacaineDrug
Experimental
bupivacaineDrug
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| liposomal bupivacaine | Experimental | These patients receive an interscalene block with liposomal bupivacaine. Receives: Drug: liposomal bupivacaine |
| bupivacaine | Active comparator | These patients receive an interscalene block with bupivacaine. Receives: Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Excursion With Sigh
Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.
Measured: change from baseline to 24 hours after block
Secondary outcomes (4)
Diaphragm Excursion With Quick Inspiratory Breath
Evaluation of diaphragm excursion (movement in cm) from rest to a quick inspiratory breath.
Measured: change from baseline to 24 hours after block
Forced Expiratory Volume in 1 Second (FEV1)
Evaluation of FEV1 via spirometry.
Measured: change from baseline to 24 hours after block
Forced Vital Capacity (FVC)
Evaluation of FVC via spirometry.
Measured: change from baseline to 24 hours after block
FEV1/FVC
Evaluation of FEV1/FVC percent via spirometry.
Measured: change from baseline to 24 hours after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Aug 2018
- Primary completion3 Jun 2020
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Phrenic Nerve ParalysisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason habeck, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636542
- Sponsor's protocol ID
- ANES-2018-26543
- Status last verified
- Nov 2022
- First submitted
- 20 Jul 2018
- Last updated
- 30 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diaphragm Movement After an Interscalene Block
- ClinicalTrials.gov ID
- NCT03636542
- Acronym / sponsor ID
- ANES-2018-26543
- Conditions
- Phrenic Nerve Paralysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine. This study will evaluate if there is a possible prolonged phrenic nerve paralysis when using liposome bupivacaine in an interscalene block, using ultrasound.
Detailed description
This study will be run concurrently with two other studies comparing bupivacaine to Liposomal Bupivacaine in shoulder surgeries. We will use already randomized patients for our randomization process. For this study in particular we will use an ultrasound machine to scan the diaphragm of any patient who had an Interscalene Block for Total Shoulder Arthroplasy or Rotator Cuff Repair. Patients are to be scanned in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as an acoustic window. M Mode will be applied and the range of diaphragmatic movement from the resting expiratory position to deep inspiration (sigh test) will be recorded as was the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). The blocks will be done regardless of the study as they are standard of care for pain control. The only intervention is ultrasound examination of the patient's diaphragm at baseline, 3 hours post block in recovery room and on post-operative day 1, and basic spirometry to record FEV1 and FVC via a portable spirometer at the same time points. If patients did stay in hospital on postoperative day 2 we would also evaluate their diaphragm function.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liposomal bupivacaine | Experimental | Drug: liposomal bupivacaineThese patients receive an interscalene block with liposomal bupivacaine. |
| bupivacaine | Active comparator | Drug: bupivacaineThese patients receive an interscalene block with bupivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients age 18 years and older who are scheduled for shoulder surgery with interscalene block and remain in the hospital for more than 24 hours that are being randomized into a bupivacaine versus liposomal bupivacaine interscalene block study.
Key exclusion criteria (1 listed)
- Non English speaking patients.
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 |
|---|---|---|
| liposomal bupivacaineExperimental | Drug | liposomal bupivacaine |
| bupivacaineActive comparator | Drug | bupivacaine |
Primary outcome
Diaphragm Excursion With Sigh
Time frame: change from baseline to 24 hours after block
Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.
4 secondary outcomes
Diaphragm Excursion With Quick Inspiratory Breath
Time frame: change from baseline to 24 hours after block
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: change from baseline to 24 hours after block
Forced Vital Capacity (FVC)
Time frame: change from baseline to 24 hours after block
FEV1/FVC
Time frame: change from baseline to 24 hours after block
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Phrenic Nerve Paralysis
Not yet recruitingPhase 4
Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery
Hemidiaphragmatic Paralysis, Postoperative Pain
Recruiting
Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
Atrial Fibrillation
Not yet recruiting
Comparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries
Spinal Cord Injuries (SCI), Sleep Disordered Breathing (SDB)
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.
Jason habeck, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing liposomal bupivacaine and bupivacaine in people with Phrenic Nerve Paralysis, run by University of Minnesota 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 1 inclusion and 1 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 30 Nov 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diaphragm Excursion With Sigh (time frame: change from baseline to 24 hours after block). 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 30 Nov 2022.