Respiratory DepressionPhase 4KTBISNCT01740453
Effect of Interscalene Block on Ventilatory Function
A Phase 4 study testing ropivacaine 2 mg/ml in people with Respiratory Depression and Anesthesia Morbidity, run by Pierre and Marie Curie University at 1 site in France.
Trial summary
Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic dysfunction). Single injection of local anesthetic induced transitory dysfunction (< 24h). The investigators hypothesized that continuous interscalene block would prolonged ventilatory impairment Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Depression, Anesthesia Morbidity, Block
- What is being tested?
- ropivacaine 2 mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Mar 2012
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgery : scheduled for elective shoulder surgery
- available for 1 month of follow up
- physical status : 1, 2, 3
Who cannot join
- body mass index > 35
- contraindication for interscalene block (local sepsis, bleeding, allergy, peripheral neuropathy)
- vital capacity less than 1.5 liters
- cardiac or renal insufficiency
- physical status >3, pregnant, weigh less than 50 kg
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalier La Pitié Salpetriere
Paris, Île-de-France Region, 75013
About this study
Official title: Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection
Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic dysfunction). Single injection of local anesthetic induced transitory dysfunction (< 24h). The investigators hypothesized that continuous interscalene block would prolonged ventilatory impairment
Read the detailed description
Unilateral pulmonary dysfunction occured after interscalene block due to phrenic nerve paralysis. This reduction induced vital capacity alteration and peek flow reduction.Several studies analysed dysfunction recovery duration after single injection using short (lidocaine)or intermediate (ropivacaine, bupivacaine)local anesthetic drug. Because continuous infusion prolonged block duration, phenic nerve may be also prolonged. However no study with continuous interscalene infusion have been performed for this dysfunction.
- Conditions
- Respiratory Depression, Anesthesia Morbidity, Block
- Being tested
- ropivacaine 2 mg/ml
- Medical subject headings
- Respiratory Insufficiency, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine 2 mg/mlDrug
single
| Study group | Role | What they receive |
|---|---|---|
| Single (no catheter) | No intervention | ropivacaine single injection : 5 mg/ml 15 ml |
| Continuous infusion | Experimental | Single injection with continuous injection ropivacaine 2 mg/ml 8 ml/h Receives: Drug: ropivacaine 2 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the pulmonary forced vital capacity
A 25 % reduction of the pulmonary forced vital capacity is expected and measured using spirometer
Measured: Day 2
Secondary outcomes (3)
Reduction of the pulmonary maximum forced expiratory flow
Outcome measure was performed using a spirometer
Measured: Day 2
Morphine consumption
Additional morphine administration for pain management (morphine intravenous : 1 mg every 7 min when necessary, pain score > 3/10)
Measured: Day 2
Pain score at rest and motion
Outcome Measure using a visual analog scale (0 to 10)
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre and Marie Curie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes
- Investigators
- Philippe Cuvillon, Md,PhD, Principal investigator, Caremeau Hospital, Nimes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740453
- Sponsor's protocol ID
- KTBIS-2012-V1
- Acronym
- KTBIS
- Status last verified
- Jan 2015
- First submitted
- 26 Nov 2012
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection
- ClinicalTrials.gov ID
- NCT01740453
- Acronym / sponsor ID
- KTBIS / KTBIS-2012-V1
- Conditions
- Respiratory Depression, Anesthesia Morbidity, Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Dec 2012 (estimated)
- 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.
Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic dysfunction). Single injection of local anesthetic induced transitory dysfunction (< 24h). The investigators hypothesized that continuous interscalene block would prolonged ventilatory impairment
Detailed description
Unilateral pulmonary dysfunction occured after interscalene block due to phrenic nerve paralysis. This reduction induced vital capacity alteration and peek flow reduction.Several studies analysed dysfunction recovery duration after single injection using short (lidocaine)or intermediate (ropivacaine, bupivacaine)local anesthetic drug. Because continuous infusion prolonged block duration, phenic nerve may be also prolonged. However no study with continuous interscalene infusion have been performed for this dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single (no catheter) | No intervention | –ropivacaine single injection : 5 mg/ml 15 ml |
| Continuous infusion | Experimental | Drug: ropivacaine 2 mg/mlSingle injection with continuous injection ropivacaine 2 mg/ml 8 ml/h |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- surgery : scheduled for elective shoulder surgery
- available for 1 month of follow up
- physical status : 1, 2, 3
Key exclusion criteria (5 listed)
- body mass index > 35
- contraindication for interscalene block (local sepsis, bleeding, allergy, peripheral neuropathy)
- vital capacity less than 1.5 liters
- cardiac or renal insufficiency
- physical status >3, pregnant, weigh less than 50 kg
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 2 mg/mlsingle | Drug | Continuous infusion |
Primary outcome
Reduction of the pulmonary forced vital capacity
Time frame: Day 2
A 25 % reduction of the pulmonary forced vital capacity is expected and measured using spirometer
3 secondary outcomes
Reduction of the pulmonary maximum forced expiratory flow
Time frame: Day 2
Morphine consumption
Time frame: Day 2
Pain score at rest and motion
Time frame: Day 2
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 19 Jan 2015.
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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.
Philippe Cuvillon, Md,PhD principal investigator
Caremeau Hospital, Nimes, France
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 ropivacaine 2 mg/ml in people with Respiratory Depression and Anesthesia Morbidity, run by Pierre and Marie Curie University 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 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 19 Jan 2015. 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 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?
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?
Reduction of the pulmonary forced vital capacity (time frame: Day 2). 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 19 Jan 2015.