Nerve BlockNCT03545295
Determination Of Dispersion In Ultrasound Guided Quadratus Lumborum Block In Cadavers
A study testing Quadratus Lumborum Block type 2 and Quadratus Lumborum Block type 3 in people with Nerve Block, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Lumbar Quadrant Blockade is a recent analgesic technique consisting of the injection of local anesthetic around the lumbar square muscle. It was initially described as a technique for abdominal wall analgesia, but later studies have increased the range of indications for laparoscopic and lower limb surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Block
- What is being tested?
- Quadratus Lumborum Block type 2 and Quadratus Lumborum Block type 3
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2018to 31 May 2019
- Phase
- Interventional
- 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
- Fresh corpses - not subjected to a formaldehyde process or frozen for more than 24 hours
- Age ≥ 18 years.
- Free, informed and informed consent signed by relatives or guardians of the body.
- Height> 150 cm and <190 cm
Who cannot join
- Previous spinal surgery.
- Significant spinal deformity
- Body mass index (BMI) ≥ 35 kg / m2
- Absence of relatives or guardians who can sign the written consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade de Misericórdia da Santa Casa De São Paulo
São Paulo, São Paulo, 01221020
Marcelo V Perez, PhD, marcelovazperez@gmail.com
Marilia Tassinari Gonçalves Preza, MD
About this study
Official title: Determination Of The Relationship Between Local Anesthetic Volume And Its Dispersion In Ultrasound Guided Quadratus Lumborum Block In Cadavers
Lumbar Quadrant Blockade is a recent analgesic technique consisting of the injection of local anesthetic around the lumbar square muscle. It was initially described as a technique for abdominal wall analgesia, but later studies have increased the range of indications for laparoscopic and lower limb surgeries. There are several techniques described but with differences in the literature at the point of injection and volume of anesthetic. The exact mechanism of visceral analgesia has not yet been determined. The objective of this study is to determine the dispersion of local anesthetic as a variable dependent on the volume of local anesthetic and injection site and elucidate the mechanisms of analgesia.
Read the detailed description
After the free and informed consent signed by the family authorizing the procedure, demographic and clinical data will be collected from the medical records of the deceased. The corpse will be weighed, measured and placed on the autopsy table. Blockade randomization (QLB 2 or QLB 3) and volume of local anesthetic (10ml, 20ml, 30ml) will be performed for each side. Injection in the anterior or posterior plane to the Lumbar Quadrant muscle will be performed by anesthesiologists experienced in the technique with ultrasound aid. A colouring solution will be used. After confirming the correct needle position, the previously randomized volumes will be injected. After the blockage, the corpse will be placed in the supine position and will be submitted to autopsy by standard procedure. After removal of the thoracic and abdominal viscera, the investigators will verify the dispersion of the local anesthetic. Photographic records will be made and the number of levels by which the solution dispersed will be annotated, calculating the number of cranial and caudal levels. The corpse will then have its autopsy procedure completed, with the placement of the viscera and incision closure according to the service standard.
- Conditions
- Nerve Block
- Being tested
- Quadratus Lumborum Block type 2, Quadratus Lumborum Block type 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum Block type 2Procedure or surgery
Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, posterior to the Quadratus Lumborum muscle
Quadratus Lumborum Block type 3Procedure or surgery
Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, anterior to the Quadratus Lumborum muscle
| Study group | Role | What they receive |
|---|---|---|
| QLB 2 10ml | Experimental | The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 10 ml coloring solution Receives: Procedure: Quadratus Lumborum Block type 2 |
| QLB 2 20ml | Experimental | The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 20 ml coloring solution Receives: Procedure: Quadratus Lumborum Block type 2 |
| QLB 2 30ml | Experimental | The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 30 ml coloring solution Receives: Procedure: Quadratus Lumborum Block type 2 |
| QLB 3 10ml | Experimental | The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 10 ml coloring solution Receives: Procedure: Quadratus Lumborum Block type 3 |
| QLB 3 20ml | Experimental | The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 20 ml coloring solution Receives: Procedure: Quadratus Lumborum Block type 3 |
| QLB 3 30ml | Experimental | The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 30 ml coloring solution Receives: Procedure: Quadratus Lumborum Block type 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spread of coloring solution according to the volume injected
Observation of coloring solution around the spinal nerves as they exit the vertebral foramen. Comparison of number of spinal nerves colored according to the volume injected.
Measured: 3 hours
Secondary outcomes (2)
Spread of coloring solution to the paravertebral space
Observation of coloring solution on the paravertebral space. Comparison of spread to the paravertebral space according to the volume injected.
Measured: 3 hours
Comparison of spread of the coloring solution between QLB 2 and QLB3
Observation of coloring solution around the spinal nerves as they exit the vertebral foramen and spread to the paravertebral space. Comparison of number of spinal nerves colored according to the technique used.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Aug 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the cadavers will be randomized to receive the intervention (Quadratus Lumborum Block) by different techniques (QLB 2/ QLB3) and different volumes (10, 20, 30 ml)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Responsible party
- Principal investigator, Marcelo Vaz Perez, Federal University of São Paulo
- Investigators
- Marilia Tassinari Gonçalves Preza, MD, Principal investigator, Post Graduate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545295
- Sponsor's protocol ID
- Quadratus Lumborum Block
- Status last verified
- May 2018
- First submitted
- 12 May 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research results will be published in indexed scientific journals, maintaining participants identity confidential
Publications
Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
PubMed 27755488Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
PubMed 26225500Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
PubMed 26735154Tamura T, Kitamura K, Yokota S, Ito S, Shibata Y, Nishiwaki K. Spread of Quadratus Lumborum Block to the Paravertebral Space Via Intramuscular Injection: A Volunteer Study. Reg Anesth Pain Med. 2018 May;43(4):372-377. doi: 10.1097/AAP.0000000000000735.
PubMed 29389680Wahal C, Kumar A, Pyati S. Advances in regional anaesthesia: A review of current practice, newer techniques and outcomes. Indian J Anaesth. 2018 Feb;62(2):94-102. doi: 10.4103/ija.IJA_433_17.
PubMed 29491513Elsharkawy H, El-Boghdadly K, Kolli S, Esa WAS, DeGrande S, Soliman LM, Drake RL. Injectate spread following anterior sub-costal and posterior approaches to the quadratus lumborum block: A comparative cadaveric study. Eur J Anaesthesiol. 2017 Sep;34(9):587-595. doi: 10.1097/EJA.0000000000000680.
PubMed 28731927Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.
PubMed 28277325Hernandez MA, Vecchione T, Boretsky K. Dermatomal spread following posterior transversus abdominis plane block in pediatric patients: our initial experience. Paediatr Anaesth. 2017 Mar;27(3):300-304. doi: 10.1111/pan.13034. Epub 2017 Jan 18.
PubMed 28098413Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
PubMed 28759502Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.
PubMed 28802593Ueshima H, Otake H. RETRACTED: Clinical experiences of unilateral anterior sub-costal quadratus lumborum block for a nephrectomy. J Clin Anesth. 2018 Feb;44:120. doi: 10.1016/j.jclinane.2017.11.031. Epub 2017 Nov 29. No abstract available.
PubMed 29195100Ueshima H, Hiroshi O. RETRACTED: Lumbar vertebra surgery performed with a bilateral posterior quadratus lumborum block. J Clin Anesth. 2017 Sep;41:61. doi: 10.1016/j.jclinane.2017.06.012. Epub 2017 Jul 3. No abstract available.
PubMed 28802611Ben-David B, La Colla L. Extravasated Fluid in Hip Arthroscopy and Pain: Is Quadratus Lumborum Block the Answer? Anesth Analg. 2017 Jul;125(1):364. doi: 10.1213/ANE.0000000000002198. No abstract available.
PubMed 28609336Gehling M, Tryba M. Risks and side-effects of intrathecal morphine combined with spinal anaesthesia: a meta-analysis. Anaesthesia. 2009 Jun;64(6):643-51. doi: 10.1111/j.1365-2044.2008.05817.x.
PubMed 19462494Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273.
PubMed 21148659
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination Of The Relationship Between Local Anesthetic Volume And Its Dispersion In Ultrasound Guided Quadratus Lumborum Block In Cadavers
- ClinicalTrials.gov ID
- NCT03545295
- Acronym / sponsor ID
- Quadratus Lumborum Block
- Conditions
- Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 4 Jun 2018 (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.
Lumbar Quadrant Blockade is a recent analgesic technique consisting of the injection of local anesthetic around the lumbar square muscle. It was initially described as a technique for abdominal wall analgesia, but later studies have increased the range of indications for laparoscopic and lower limb surgeries. There are several techniques described but with differences in the literature at the point of injection and volume of anesthetic. The exact mechanism of visceral analgesia has not yet been determined. The objective of this study is to determine the dispersion of local anesthetic as a variable dependent on the volume of local anesthetic and injection site and elucidate the mechanisms of analgesia.
Detailed description
After the free and informed consent signed by the family authorizing the procedure, demographic and clinical data will be collected from the medical records of the deceased. The corpse will be weighed, measured and placed on the autopsy table. Blockade randomization (QLB 2 or QLB 3) and volume of local anesthetic (10ml, 20ml, 30ml) will be performed for each side. Injection in the anterior or posterior plane to the Lumbar Quadrant muscle will be performed by anesthesiologists experienced in the technique with ultrasound aid. A colouring solution will be used. After confirming the correct needle position, the previously randomized volumes will be injected. After the blockage, the corpse will be placed in the supine position and will be submitted to autopsy by standard procedure. After removal of the thoracic and abdominal viscera, the investigators will verify the dispersion of the local anesthetic. Photographic records will be made and the number of levels by which the solution dispersed will be annotated, calculating the number of cranial and caudal levels. The corpse will then have its autopsy procedure completed, with the placement of the viscera and incision closure according to the service standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- the cadavers will be randomized to receive the intervention (Quadratus Lumborum Block) by different techniques (QLB 2/ QLB3) and different volumes (10, 20, 30 ml)
| Arm | Type | Receives |
|---|---|---|
| QLB 2 10ml | Experimental | Procedure: Quadratus Lumborum Block type 2The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 10 ml coloring solution |
| QLB 2 20ml | Experimental | Procedure: Quadratus Lumborum Block type 2The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 20 ml coloring solution |
| QLB 2 30ml | Experimental | Procedure: Quadratus Lumborum Block type 2The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 30 ml coloring solution |
| QLB 3 10ml | Experimental | Procedure: Quadratus Lumborum Block type 3The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 10 ml coloring solution |
| QLB 3 20ml | Experimental | Procedure: Quadratus Lumborum Block type 3The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 20 ml coloring solution |
| QLB 3 30ml | Experimental | Procedure: Quadratus Lumborum Block type 3The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 30 ml coloring solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fresh corpses - not subjected to a formaldehyde process or frozen for more than 24 hours
- Age ≥ 18 years.
- Free, informed and informed consent signed by relatives or guardians of the body.
- Height> 150 cm and <190 cm
Key exclusion criteria (4 listed)
- Previous spinal surgery.
- Significant spinal deformity
- Body mass index (BMI) ≥ 35 kg / m2
- Absence of relatives or guardians who can sign the written consent
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 |
|---|---|---|
| Quadratus Lumborum Block type 2Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, posterior to the Quadratus Lumborum muscle | Procedure or surgery | QLB 2 10ml, QLB 2 20ml, QLB 2 30ml |
| Quadratus Lumborum Block type 3Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, anterior to the Quadratus Lumborum muscle | Procedure or surgery | QLB 3 10ml, QLB 3 20ml, QLB 3 30ml |
Primary outcome
Spread of coloring solution according to the volume injected
Time frame: 3 hours
Observation of coloring solution around the spinal nerves as they exit the vertebral foramen. Comparison of number of spinal nerves colored according to the volume injected.
2 secondary outcomes
Spread of coloring solution to the paravertebral space
Time frame: 3 hours
Comparison of spread of the coloring solution between QLB 2 and QLB3
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Background: PubMed 27755488Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
- Background: PubMed 26225500Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
- Background: PubMed 26735154Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
- Background: PubMed 29389680Tamura T, Kitamura K, Yokota S, Ito S, Shibata Y, Nishiwaki K. Spread of Quadratus Lumborum Block to the Paravertebral Space Via Intramuscular Injection: A Volunteer Study. Reg Anesth Pain Med. 2018 May;43(4):372-377. doi: 10.1097/AAP.0000000000000735.
- Background: PubMed 29491513Wahal C, Kumar A, Pyati S. Advances in regional anaesthesia: A review of current practice, newer techniques and outcomes. Indian J Anaesth. 2018 Feb;62(2):94-102. doi: 10.4103/ija.IJA_433_17.
- Background: PubMed 28731927Elsharkawy H, El-Boghdadly K, Kolli S, Esa WAS, DeGrande S, Soliman LM, Drake RL. Injectate spread following anterior sub-costal and posterior approaches to the quadratus lumborum block: A comparative cadaveric study. Eur J Anaesthesiol. 2017 Sep;34(9):587-595. doi: 10.1097/EJA.0000000000000680.
- Background: PubMed 28277325Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.
- Background: PubMed 28098413Hernandez MA, Vecchione T, Boretsky K. Dermatomal spread following posterior transversus abdominis plane block in pediatric patients: our initial experience. Paediatr Anaesth. 2017 Mar;27(3):300-304. doi: 10.1111/pan.13034. Epub 2017 Jan 18.
- Background: PubMed 28759502Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.
- Background: PubMed 28802593Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.
- Background: PubMed 29195100Ueshima H, Otake H. RETRACTED: Clinical experiences of unilateral anterior sub-costal quadratus lumborum block for a nephrectomy. J Clin Anesth. 2018 Feb;44:120. doi: 10.1016/j.jclinane.2017.11.031. Epub 2017 Nov 29. No abstract available.
- Background: PubMed 28802611Ueshima H, Hiroshi O. RETRACTED: Lumbar vertebra surgery performed with a bilateral posterior quadratus lumborum block. J Clin Anesth. 2017 Sep;41:61. doi: 10.1016/j.jclinane.2017.06.012. Epub 2017 Jul 3. No abstract available.
- Individual participant dataSharing planned: No. The research results will be published in indexed scientific journals, maintaining participants identity confidential
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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.
Marilia Tassinari Gonçalves Preza, MD principal investigator
Post Graduate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum Block type 2 and Quadratus Lumborum Block type 3 in people with Nerve Block, run by Federal University of São Paulo at 1 site in Brazil.
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 4 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: status not confirmed, as of the sponsor's last update on 4 Jun 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo V Perez, PhD (+551121767000, marcelovazperez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spread of coloring solution according to the volume injected (time frame: 3 hours). 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 NCT03545295, which also lists 16 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 4 Jun 2018.