Diaphragmatic ParalysisPhase 3NUMEROBISNCT04173364
Interscalene Block and Dysfunction Diaphragmatic
A Phase 3 study testing Ropivacaine 0.5% Injectable Solution and Ropivacaine 0.1% Injectable Solution in people with Diaphragmatic Paralysis, run by University Hospital, Lille at 1 site in France.
Trial summary
The study seeks to show that interscalene injection of a small volume (<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragmatic Paralysis
- What is being tested?
- Ropivacaine 0.5% Injectable Solution and Ropivacaine 0.1% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Oct 2019to 21 Sep 2020
- Phase
- Phase 3
- 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
Who may be able to join
- orthopedic surgery compatible with interscalene block
- french speaking
- Patient who signed consent to participate in the study
Who cannot join
- Pregnant woman
- ASA score > 3
- Severe chronic respiratory insufficiency
- COPD >3 or 4 of Gold score
- coagulation trouble
- Allergic to medication involved in the study
- Breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interscalene Block and Dysfunction Diaphragmatic: Effect of Low Volume of Ropivacaine 0,1%. A Randomised, Controlled Trial
The study seeks to show that interscalene injection of a small volume (<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB.
Read the detailed description
It's a prospective monocentric randomized controlled clinical trial in 2 parallel groups in double blind.
the study concerns patients undergoing arthroscopic shoulder surgery with ISB. The study seeks to show that interscalene injection of a small volume (<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB.
Randomization in one of the two arms:
- Experimental group: <8ml ropivacaine 0.1%.
- Control group: <8mL of ropivacaine 0.5%.
Evaluation of diaphragmatic stroke by ultrasound and ventilatory function by spirometry and snip test before performing the ISB, then after installation of the ISB.
Performing the surgical procedure under general anesthesia assessment of postoperative analgesia and patient satisfaction during the following 48 hours.
- Conditions
- Diaphragmatic Paralysis
- Being tested
- Ropivacaine 0.5% Injectable Solution, Ropivacaine 0.1% Injectable Solution
- Keywords
- interscalene block, shoulder surgery, local anesthesic, respiratory function, diaphragmatic dysfunction, echography, locoregional anesthesia
- Medical subject headings
- Respiratory Paralysis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.5% Injectable SolutionDrug
Also called naropeine 0.5%
Injectable solution of ropivacaine 0.5%
Ropivacaine 0.1% Injectable SolutionDrug
Also called Naropeine 0.1%
Dilution of ropivacaine to the concentration of 0.1%
| Study group | Role | What they receive |
|---|---|---|
| Experimental group : ropivacaine 0.1% | Experimental | Interscalene block for arthroscopic shoulder surgery with small volume of low concentration (0.1%) of ropivacaine Receives: Drug: Ropivacaine 0.1% Injectable Solution |
| control group : ropivacaine 0.5% | Active comparator | Interscalene block for arthroscopic shoulder surgery with small volume of standard concentration (0.5%) of ropivacaine Receives: Drug: Ropivacaine 0.5% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the occurrence of hemi-diaphragmatic paresis
Hemi diaphragmatic paresis is evaluated by quantifying the homolateral diaphragmatic stroke at interscalene block (ISB) by ultrasound analysis (measured in centimeter), during slow and deep inspiration. Diaphragmatic hemiparesis is defined as a decrease (at post-ISB time vs. pre-ISB time) of more than 25% of the diaphragmatic stroke during this slow and deep inspiration.
Measured: 1h after interscalene block
Secondary outcomes (6)
Compare the frequency of hemi-diaphragmatic paralysis
Hemi-diaphragmatic paralysis refers to the absence of diaphragmatic movement (or paradoxical movement) in ultrasound during rest ventilation and slow, deep inhalation.
Measured: 1h after interscalene block
Compare intraoperative analgesia
Total consumption of sufentanil, and Analgesia Nociception Index values (ANI, MetroDoloris, France).
Measured: peroperative time
Compare postoperative analgesia
Duration of effective analgesia (defined as the period up to the first EVA > 3 (excluding PACU Consumption of morphine in PACU and analgesics within the first 24 hours.
Measured: 24 hours postoperatively
Compare the ventilatory function (spirometry and snip test).
Presence of a respiratory impairment detected by spirometry (Spiro-USB® device) and presence of a diaphragmatic impairment detected by snip test, (micro-RPM®). Ventilation impairment will be considered present if there is a decrease of at least 25% in vital capacity between the pre and post ISB. Diaphragmatic damage is defined as a decrease of at least 25% in the Snip-test values between the pre and post ISB.
Measured: 1h after interscalene block
Compare patient satisfaction
Evaluation of patient satisfaction by questionnaire at the patient's bedside or by telephone call within 24h-48h postoperatively. It is assessed on a numerical scale from 0 to 10 (0 being the lowest satisfaction value and 10 the highest value)
Measured: 24 to 48 hours postoperatively
Compare the contralateral diaphragmatic stroke
Evaluation of contralateral diaphragmatic compensation (diaphragmatic stroke in ultrasound, comparison of post-ISB time vs. pre-ISB time, expressed in %).
Measured: 1h after interscalene block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start29 Oct 2019
- Primary completion21 Sep 2020
- Study completion21 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragmatic ParalysisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud ALLUIN, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173364
- Sponsor's protocol ID
- 2018_66
- Other IDs
- 2019-001984-62, 2019
- Acronym
- NUMEROBIS
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2019
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Verbeke AL, Jeanneteau A, Bellet J, Genin M, Cirenei C, Alluin A, Tavernier B. The diaphragm-sparing effect of interscalene block with a low-volume of ropivacaine 0.1% vs. 0.5%: A double-blind, controlled, randomised trial. Eur J Anaesthesiol Intensive Care. 2026 Apr 23;5(3):e0108. doi: 10.1097/EA9.0000000000000108. eCollection 2026 Jun.
PubMed 42244823
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene Block and Dysfunction Diaphragmatic: Effect of Low Volume of Ropivacaine 0,1%. A Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT04173364
- Acronym / sponsor ID
- NUMEROBIS / 2018_66
- Conditions
- Diaphragmatic Paralysis
- Keywords
- interscalene block, shoulder surgery, local anesthesic, respiratory function, diaphragmatic dysfunction, echography, locoregional anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 21 Nov 2019 (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 seeks to show that interscalene injection of a small volume (<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB.
Detailed description
It's a prospective monocentric randomized controlled clinical trial in 2 parallel groups in double blind.
the study concerns patients undergoing arthroscopic shoulder surgery with ISB. The study seeks to show that interscalene injection of a small volume (<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB.
Randomization in one of the two arms:
- Experimental group: <8ml ropivacaine 0.1%.
- Control group: <8mL of ropivacaine 0.5%.
Evaluation of diaphragmatic stroke by ultrasound and ventilatory function by spirometry and snip test before performing the ISB, then after installation of the ISB.
Performing the surgical procedure under general anesthesia assessment of postoperative analgesia and patient satisfaction during the following 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group : ropivacaine 0.1% | Experimental | Drug: Ropivacaine 0.1% Injectable SolutionInterscalene block for arthroscopic shoulder surgery with small volume of low concentration (0.1%) of ropivacaine |
| control group : ropivacaine 0.5% | Active comparator | Drug: Ropivacaine 0.5% Injectable SolutionInterscalene block for arthroscopic shoulder surgery with small volume of standard concentration (0.5%) of ropivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- orthopedic surgery compatible with interscalene block
- french speaking
- Patient who signed consent to participate in the study
Key exclusion criteria (7 listed)
- Pregnant woman
- ASA score > 3
- Severe chronic respiratory insufficiency
- COPD >3 or 4 of Gold score
- coagulation trouble
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 |
|---|---|---|
| Ropivacaine 0.5% Injectable SolutionAlso: naropeine 0.5%Injectable solution of ropivacaine 0.5% | Drug | control group : ropivacaine 0.5% |
| Ropivacaine 0.1% Injectable SolutionAlso: Naropeine 0.1%Dilution of ropivacaine to the concentration of 0.1% | Drug | Experimental group : ropivacaine 0.1% |
Primary outcome
Compare the occurrence of hemi-diaphragmatic paresis
Time frame: 1h after interscalene block
Hemi diaphragmatic paresis is evaluated by quantifying the homolateral diaphragmatic stroke at interscalene block (ISB) by ultrasound analysis (measured in centimeter), during slow and deep inspiration. Diaphragmatic hemiparesis is defined as a decrease (at post-ISB time vs. pre-ISB time) of more than 25% of the diaphragmatic stroke during this slow and deep inspiration.
6 secondary outcomes
Compare the frequency of hemi-diaphragmatic paralysis
Time frame: 1h after interscalene block
Compare intraoperative analgesia
Time frame: peroperative time
Compare postoperative analgesia
Time frame: 24 hours postoperatively
Compare the ventilatory function (spirometry and snip test).
Time frame: 1h after interscalene block
Compare patient satisfaction
Time frame: 24 to 48 hours postoperatively
Compare the contralateral diaphragmatic stroke
Time frame: 1h after interscalene block
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 11 Jun 2026.
- Results publication: PubMed 42244823Verbeke AL, Jeanneteau A, Bellet J, Genin M, Cirenei C, Alluin A, Tavernier B. The diaphragm-sparing effect of interscalene block with a low-volume of ropivacaine 0.1% vs. 0.5%: A double-blind, controlled, randomised trial. Eur J Anaesthesiol Intensive Care. 2026 Apr 23;5(3):e0108. doi: 10.1097/EA9.0000000000000108. eCollection 2026 Jun.
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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.
Arnaud ALLUIN, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine 0.5% Injectable Solution and Ropivacaine 0.1% Injectable Solution in people with Diaphragmatic Paralysis, run by University Hospital, Lille at 1 site in France.
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 3 inclusion and 7 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 11 Jun 2026. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Compare the occurrence of hemi-diaphragmatic paresis (time frame: 1h after interscalene block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04173364, which also lists 1 linked publication.
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 11 Jun 2026.