Diaphragmatic ParalysisPhase 3REDOLEV-2019NCT04385966
Diaphragmatic Paralysis Comparison Between Local Anesthetic Volumen Doses After Interscalene Block
A Phase 3 study testing Interscalene brachial plexus block and Levobupivacaine Hydrochloride 2.5 MG/ML in people with Diaphragmatic Paralysis and Brachial Plexus Block, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
Trial summary
Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphragmatic Paralysis, Brachial Plexus Block
- What is being tested?
- Interscalene brachial plexus block and Levobupivacaine Hydrochloride 2.5 MG/ML
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2020to 20 Oct 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years.
- ASA I-III.
- Scheduled for shoulder arthroscopic shoulder surgery and interscalene brachial plexus block.
Who cannot join
- Age <18 and >80 years.
- Pregnancy.
- Exclusión to perform IBPB or spirometry.
- Allergy to amide group local anaesthetics, opioids or nonsteroidal anti-inflammatory drugs.
- Background of Pulmonary diseases (chronic obstructive pulmonary disease (COPD) and moderate, severe or not well-controlled asthma), diaphragmatic paralysis or neurological disease with diaphragmatic dysfunction, brachial plexus neuropathy or chronic opioid consumption (more than 3-months consumption or more than oral Morphine 1 mg 1-month).
- Coagulation disorders (INR>3, TTPA > 35 y AP <50%).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diaphragmatic Paralysis After Interscalene Brachial Plexus Block: A Randomized, Double-blinded, Unicenter and Controlled Clinical Trial to Reduce the Dose of Levobupivacaine 0,25% 20 ml to 10 ml Undergoing Arthroscopic Shoulder Surgery
Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA).
This is a comparative, prospective, Unicenter, double-blind, two-arm, randomized and controlled clinical trial. 48 patients will be included.
This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.
Read the detailed description
Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA).
The primary study objective is to determine the HDPA diagnosed by using diaphragmatic thickness index in Ultrasound (US) after Low Volume (10 mL) versus Standard Volume (20 mL) of Levobupivacaine 0,25% for IBPB. Secondary end-points are 1) HDPA diagnosed by using FVC and FEV1 in spirometry, 2) HDPA diagnosed by using diaphragmatic excursion in US, 3) postoperative pain regarding time to first analgesic consumption and 24-hour cumulative total consumption of Patient-controlled analgesia (PCA) pump of Morphine IV and (4) postoperative harms between two trial-arms.
This study is a comparative, prospective, Unicenter, double-blind and two-arm RCT. 48 patients will be included.
This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.
- Conditions
- Diaphragmatic Paralysis, Brachial Plexus Block
- Being tested
- Interscalene brachial plexus block, Levobupivacaine Hydrochloride 2.5 MG/ML
- Keywords
- Diaphragmatic Paralysis, Interscalene Brachial Plexus Block, Ultrasound, Postoperative pain, Arthroscopic shoulder surgery.
- Medical subject headings
- Respiratory Paralysis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockProcedure or surgery
Also called MeSH Unique ID: D065527, CIE-10 code 3E0T3CZ, Interscalene block
Interscalene brachial plexus block is a locorregional anaesthesia technique which is indicated in shoulder and upper arm surgery. The goal of this block is to place the needle in the tissue space between the anterior and middle scalene muscles and inject local anesthetic until the spread around the brachial plexus is documented by ultrasound.
Levobupivacaine Hydrochloride 2.5 MG/MLDrug
Also called Chirocaine® 2.5 MG/ML
Levobupivacaine Hydrochloride 2.5 MG/ML is an anesthestic product intended for epidural, intradural and perineural administration. Levobupivacaine is chemically described as (S)-l-butyl-2-piperidylformo-2',6'-xylidide hydrochloride. It is a white crystalline powder with a molecular formula of C18H28N2O. HCl, with a molecular weight 324.9.
FDA approval: NDA-20997 (1999).
| Study group | Role | What they receive |
|---|---|---|
| Standard Volume Dose | Active comparator | 24 patients will be included in the Standard Volume Dose arm. 20 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery. Receives: Procedure: Interscalene brachial plexus block; Drug: Levobupivacaine Hydrochloride 2.5 MG/ML |
| Low Volume Dose | Experimental | 24 patients will be included in the Low Volume Dose arm. 10 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery. Receives: Procedure: Interscalene brachial plexus block; Drug: Levobupivacaine Hydrochloride 2.5 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Diaphragmatic Thickness Ratio at 4 hours
The primary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to diaphragmatic thickness ratio (DTR) in ultrasounds between the Treatment and Control groups. DTR will be the result of Inspiratory Diaphragmatic Thickness and Expiratory Diaphragmatic Thickness. The ratio will be defined by DTR=IDT/EDT. HDPA after IBPB at 4 hours will be diagnosed with a DTR<1.2.
Measured: Before (Baseline) and 4-hour after interscalene brachial plexus block
Secondary outcomes (6)
Change from Baseline FVC at 4 hours and 24 hours
This secondary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to Forced Vital Capacity (FVC) in spirometry. HDPA will be diagnosed with a CVF diminution of >20%.
Measured: Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block
Change from Baseline FEV1 at 4 hours and 24 hours
This secondary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to forced expiratory volume in one second (FEV1) in spirometry. HDPA will be diagnosed with a FEV1 diminution of >20%.
Measured: Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block
Change from Baseline Diaphragmatic excursion at 4 hours and 24 hours
This secondary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to Diaphragmatic excursion expressed as number of intercostal spaces and motion type. HDPA will be diagnosed with a reduction of >25% number of intercostal spaces or a paradoxal or nule diaphragmatic motion.
Measured: Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block
Postoperative IV morphine consumption
This secondary outcome is the postoperative 24-hour cumulative IV morphine consumption (mg) of Patient controlled analgesia (PCA) pump.
Measured: From 4-hour to 24-hour after interscalene brachial plexus block
Postoperative time to first analgesic consumption
This secondary outcome is the time to first analgesic consumption (minutes) of Patient controlled analgesia (PCA) pump.
Measured: From 4-hour to 24-hour after interscalene brachial plexus block
Incidence and frequency of Serious Adverse Events (SAE)
This secondary outcome is the incidence, frequency and severity of Serious Adverse Events (SAE) as assessed by CTCAE v4.0 in the two study groups
Measured: From performing the interscalene brachial plexus block to finish the 24-hour postoperative follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start11 Feb 2020
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The REDOLEV study is a randomized, comparative, prospective, unicenter, double-blind, two-arm and controlled Clinical trial (RCT).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Miguel Servet
- Responsible party
- Sponsor
- Investigators
- Pablo O Forniés, MD, Principal investigator, Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385966
- Sponsor's protocol ID
- REDOLEV-2019
- Acronym
- REDOLEV-2019
- Status last verified
- Aug 2021
- First submitted
- 16 Apr 2020
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be available on file in storage and on the Internet (URL undecided yet) after finishing the data collection for 25 years at the participating site.
Publications
Lopez Escarraga VM, Dubos Espana K, Castillo Bustos RH, Peidro L, Sastre S, Sala-Blanch X. Diaphragmatic thickness ratio (inspiratory/expiratory) as a diagnostic method of diaphragmatic palsy associated with interescalene block. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):81-89. doi: 10.1016/j.redar.2017.09.008. Epub 2017 Nov 7. English, Spanish.
PubMed 29126611Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.
PubMed 1539813Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PubMed 2006740Thackeray EM, Swenson JD, Gertsch MC, Phillips KM, Steele JW, Burks RT, Tashjian RZ, Greis PE. Diaphragm function after interscalene brachial plexus block: a double-blind, randomized comparison of 0.25% and 0.125% bupivacaine. J Shoulder Elbow Surg. 2013 Mar;22(3):381-6. doi: 10.1016/j.jse.2012.06.011. Epub 2012 Sep 1.
PubMed 22947235Stundner O, Meissnitzer M, Brummett CM, Moser S, Forstner R, Kokofer A, Danninger T, Gerner P, Kirchmair L, Fritsch G. Comparison of tissue distribution, phrenic nerve involvement, and epidural spread in standard- vs low-volume ultrasound-guided interscalene plexus block using contrast magnetic resonance imaging: a randomized, controlled trial. Br J Anaesth. 2016 Mar;116(3):405-12. doi: 10.1093/bja/aev550.
PubMed 26865133Oliver-Fornies P, Ortega Lahuerta JP, Gomez Gomez R, Gonzalo Pellicer I, Oliden Gutierrez L, Vinuales Cabeza J, Gallego Ligorit L, Orellana Melgar CE. Diaphragmatic paralysis, respiratory function, and postoperative pain after interscalene brachial plexus block with a reduced dose of 10 ml levobupivacaine 0.25% versus a 20 ml dose in patients undergoing arthroscopic shoulder surgery: study protocol for the randomized controlled double-blind REDOLEV study. Trials. 2021 Apr 19;22(1):287. doi: 10.1186/s13063-021-05216-6.
PubMed 33874993
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Paralysis After Interscalene Brachial Plexus Block: A Randomized, Double-blinded, Unicenter and Controlled Clinical Trial to Reduce the Dose of Levobupivacaine 0,25% 20 ml to 10 ml Undergoing Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04385966
- Acronym / sponsor ID
- REDOLEV-2019 / REDOLEV-2019
- Conditions
- Diaphragmatic Paralysis, Brachial Plexus Block
- Keywords
- Diaphragmatic Paralysis, Interscalene Brachial Plexus Block, Ultrasound, Postoperative pain, Arthroscopic shoulder surgery.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Collaborators
- Hospital Miguel Servet
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 13 May 2020 (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.
Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA).
This is a comparative, prospective, Unicenter, double-blind, two-arm, randomized and controlled clinical trial. 48 patients will be included.
This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.
Detailed description
Arthroscopic shoulder surgery involves dynamic and severe postoperative pain. Interscalene brachial plexus block (IBPB) provides adequate analgesia but the spread of local anaesthetics administered causes a phrenic nerve block which entrains a non-negligible incidence of Hemidiaphragmatic paralysis acute (HDPA).
The primary study objective is to determine the HDPA diagnosed by using diaphragmatic thickness index in Ultrasound (US) after Low Volume (10 mL) versus Standard Volume (20 mL) of Levobupivacaine 0,25% for IBPB. Secondary end-points are 1) HDPA diagnosed by using FVC and FEV1 in spirometry, 2) HDPA diagnosed by using diaphragmatic excursion in US, 3) postoperative pain regarding time to first analgesic consumption and 24-hour cumulative total consumption of Patient-controlled analgesia (PCA) pump of Morphine IV and (4) postoperative harms between two trial-arms.
This study is a comparative, prospective, Unicenter, double-blind and two-arm RCT. 48 patients will be included.
This RCT would demonstrate a low volume dose IBPB decrease the HDPA after IBPB in patients undergoing SAS, by using spirometry and ultrasound and it will not provide inferior postoperative analgesia according to opioid requirements of postoperative PCA in comparison to standard volume dose used in current practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The REDOLEV study is a randomized, comparative, prospective, unicenter, double-blind, two-arm and controlled Clinical trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Standard Volume Dose | Active comparator | Procedure: Interscalene brachial plexus block, Drug: Levobupivacaine Hydrochloride 2.5 MG/ML24 patients will be included in the Standard Volume Dose arm. 20 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery. |
| Low Volume Dose | Experimental | Procedure: Interscalene brachial plexus block, Drug: Levobupivacaine Hydrochloride 2.5 MG/ML24 patients will be included in the Low Volume Dose arm. 10 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 80 years.
- ASA I-III.
- Scheduled for shoulder arthroscopic shoulder surgery and interscalene brachial plexus block.
Key exclusion criteria (6 listed)
- Age <18 and >80 years.
- Pregnancy.
- Exclusión to perform IBPB or spirometry.
- Allergy to amide group local anaesthetics, opioids or nonsteroidal anti-inflammatory drugs.
- Background of Pulmonary diseases (chronic obstructive pulmonary disease (COPD) and moderate, severe or not well-controlled asthma), diaphragmatic paralysis or neurological disease with diaphragmatic dysfunction, brachial plexus neuropathy or chronic opioid consumption (more than 3-months consumption or more than oral Morphine 1 mg 1-month).
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 |
|---|---|---|
| Interscalene brachial plexus blockAlso: MeSH Unique ID: D065527, CIE-10 code 3E0T3CZ, Interscalene blockInterscalene brachial plexus block is a locorregional anaesthesia technique which is indicated in shoulder and upper arm surgery. The goal of this block is to place the needle in the tissue space between the anterior and middle scalene muscles and inject local anesthetic until the spread around the brachial plexus is documented by ultrasound. | Procedure or surgery | Low Volume Dose, Standard Volume Dose |
| Levobupivacaine Hydrochloride 2.5 MG/MLAlso: Chirocaine® 2.5 MG/MLLevobupivacaine Hydrochloride 2.5 MG/ML is an anesthestic product intended for epidural, intradural and perineural administration. Levobupivacaine is chemically described as (S)-l-butyl-2-piperidylformo-2',6'-xylidide hydrochloride. It is a white crystalline powder with a molecular formula of C18H28N2O. HCl, with a molecular weight 324.9. FDA approval: NDA-20997 (1999). | Drug | Low Volume Dose, Standard Volume Dose |
Primary outcome
Change from Baseline Diaphragmatic Thickness Ratio at 4 hours
Time frame: Before (Baseline) and 4-hour after interscalene brachial plexus block
The primary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to diaphragmatic thickness ratio (DTR) in ultrasounds between the Treatment and Control groups. DTR will be the result of Inspiratory Diaphragmatic Thickness and Expiratory Diaphragmatic Thickness. The ratio will be defined by DTR=IDT/EDT. HDPA after IBPB at 4 hours will be diagnosed with a DTR<1.2.
6 secondary outcomes
Change from Baseline FVC at 4 hours and 24 hours
Time frame: Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block
Change from Baseline FEV1 at 4 hours and 24 hours
Time frame: Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block
Change from Baseline Diaphragmatic excursion at 4 hours and 24 hours
Time frame: Before (Baseline), 4-hour and 24-hour after interscalene brachial plexus block
Postoperative IV morphine consumption
Time frame: From 4-hour to 24-hour after interscalene brachial plexus block
Postoperative time to first analgesic consumption
Time frame: From 4-hour to 24-hour after interscalene brachial plexus block
Incidence and frequency of Serious Adverse Events (SAE)
Time frame: From performing the interscalene brachial plexus block to finish the 24-hour postoperative follow-up
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 2022.
- Background: PubMed 29126611Lopez Escarraga VM, Dubos Espana K, Castillo Bustos RH, Peidro L, Sastre S, Sala-Blanch X. Diaphragmatic thickness ratio (inspiratory/expiratory) as a diagnostic method of diaphragmatic palsy associated with interescalene block. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):81-89. doi: 10.1016/j.redar.2017.09.008. Epub 2017 Nov 7. English, Spanish.
- Background: PubMed 1539813Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.
- Background: PubMed 2006740Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
- Background: PubMed 22947235Thackeray EM, Swenson JD, Gertsch MC, Phillips KM, Steele JW, Burks RT, Tashjian RZ, Greis PE. Diaphragm function after interscalene brachial plexus block: a double-blind, randomized comparison of 0.25% and 0.125% bupivacaine. J Shoulder Elbow Surg. 2013 Mar;22(3):381-6. doi: 10.1016/j.jse.2012.06.011. Epub 2012 Sep 1.
- Background: PubMed 26865133Stundner O, Meissnitzer M, Brummett CM, Moser S, Forstner R, Kokofer A, Danninger T, Gerner P, Kirchmair L, Fritsch G. Comparison of tissue distribution, phrenic nerve involvement, and epidural spread in standard- vs low-volume ultrasound-guided interscalene plexus block using contrast magnetic resonance imaging: a randomized, controlled trial. Br J Anaesth. 2016 Mar;116(3):405-12. doi: 10.1093/bja/aev550.
- Derived from this study: PubMed 33874993Oliver-Fornies P, Ortega Lahuerta JP, Gomez Gomez R, Gonzalo Pellicer I, Oliden Gutierrez L, Vinuales Cabeza J, Gallego Ligorit L, Orellana Melgar CE. Diaphragmatic paralysis, respiratory function, and postoperative pain after interscalene brachial plexus block with a reduced dose of 10 ml levobupivacaine 0.25% versus a 20 ml dose in patients undergoing arthroscopic shoulder surgery: study protocol for the randomized controlled double-blind REDOLEV study. Trials. 2021 Apr 19;22(1):287. doi: 10.1186/s13063-021-05216-6.
- Individual participant dataSharing planned: Yes. All collected IPD will be available on file in storage and on the Internet (URL undecided yet) after finishing the data collection for 25 years at the participating site.
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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.
Pablo O Forniés, MD principal investigator
Hospital Miguel Servet
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 Interscalene brachial plexus block and Levobupivacaine Hydrochloride 2.5 MG/ML in people with Diaphragmatic Paralysis and Brachial Plexus Block, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
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 6 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 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 Spain. 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?
Change from Baseline Diaphragmatic Thickness Ratio at 4 hours (time frame: Before (Baseline) and 4-hour after interscalene brachial plexus 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 NCT04385966, which also lists 6 linked publications.
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 2022.