Pain, PostoperativeNCT04013815
Erector Spinae Plane Block for Post-thoracotomy Pain
A study testing erector spinae plane block with ropivacaine and Intercostal nerve block with ropivacaine in people with Pain, Postoperative, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Post-thoracotomy pain is one of the most severe forms of post-operative pain. Among the most common techniques for the management of post-thoracotomy pain, there are the intercostal nerve block, and a recently described block, the erector spinae plane block (ESP).To date, there are no studies that compare the efficacy… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- erector spinae plane block with ropivacaine and Intercostal nerve block with ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2019to 30 Nov 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing thoracotomy lung resection surgery between 45 and 80 years
Who cannot join
- Patients allergic to the drugs used in the study
- Patients with diabetic neuropathy
- Patients with severe hepatic or renal insufficiency
- emergent surgery
- Age <45 years or> 80 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Versus Intrapleural Intercostal Plane Block for Post-thoracotomy Pain: a Randomized Trial
Post-thoracotomy pain is one of the most severe forms of post-operative pain. Among the most common techniques for the management of post-thoracotomy pain, there are the intercostal nerve block, and a recently described block, the erector spinae plane block (ESP).To date, there are no studies that compare the efficacy of ESP block with other pain relief methods in acute post-thoracotomy pain. The objective of this randomized study is to compare the analgesic efficacy of these two techniques in the control of acute post-thoracotomy chest pain, block of erector spinae vs intrapleural intercostal block.
Read the detailed description
Post-thoracotomy pain is one of the most severe forms of post-operative pain that can be attributed to muscle incision, rib retraction or resection, and damage to the intercostal nerves. Inadequate control of this post-operative pain can contribute to a deterioration of the respiratory function, with limitation of the ventilation, appearance of atelectasis, ineffective cough, and increased risk of infectious complications. Moreover, recent evidence shows that persistent pain after surgery, in addition to being responsible for chronic post-surgical pain syndrome, is associated with a delay in post-operative recovery and a return to normal daily life activities. The most common techniques for the management of post-thoracotomy pain are in addition to systemic intravenous analgesia, thoracic epidural, paravertebral nerve block and intercostal nerve block. Although the thoracic epidural has been considered for years the gold standard for the control of post-operative pain following thoracotomy, it is not risk-free, requires an expert operator, and can be contraindicated in some categories of patients. The intercostal nerve block, performed through the injection of the local anesthetic in multiple intercostal spaces before performing thoracotomy, may be one of the alternatives to a thoracic epidural in terms of safety and efficacy and is technically easy and quick to perform. This block is found to be particularly effective in reducing post-operative pain when associated with a mini-thoracotomy, helping to improve the outcome of patients undergoing major lung resection. A technique of more recent description (2016) is the erector spinae plane block (ESP) . This interfascial block is performed in the posterior thoracic region homolaterally at the site of the intervention at the level of the T5 transverse process (fifth thoracic vertebra), the ultrasound marker of the block. The ESP block is easy and safe to perform thanks to the ultrasound-guided method and the absence of vascular-nerve structures at risk of damage in the vicinity of the injection site and allows analgesia of the posterior and anterolateral thoracic wall and of the axillary region. In fact, cadaveric studies have shown an anesthetic distribution both in the cranial caudal sense (T2-T8) along the fascia between erector spinae and large rhomboid, and in the anteroposterior direction, with the blockage of the spinal thoracic nerve roots. ESP block was described in the treatment of chronic chest pain in the first place, but was subsequently used as rescue therapy in acute post-thoracotomy pain; it has also been tested in upper abdominal surgery, performed bilaterally. Use in four cases of acute post video thoracoscopy pain management has also been described. Recently, some randomized controlled trials have been carried out that showed: greater analgesic efficacy of ESP compared to intravenous multimodal analgesia standard for the treatment of post-operative pain, with less recourse to rescue doses of morphine following laparoscopic cholecystectomy, mastectomy and cardiac surgery. To date, there are no studies that compare its efficacy with other pain relief methods in acute post-thoracotomy pain. The objective of our study is to compare the analgesic efficacy of these two techniques in the control of acute post-thoracotomy chest pain, blockade of erector spinae vs intrapleural intercostal blockade.
- Conditions
- Pain, Postoperative
- Being tested
- erector spinae plane block with ropivacaine, Intercostal nerve block with ropivacaine
- Keywords
- erector spinae plane block, thoracotomy, ultrasound guided nerve block, analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane block with ropivacaineProcedure or surgery
The block is performed immediately before surgery. by an ultrasound guide, with the probe positioned longitudinally, the spinous process of T5 is identified. A peripheral block needle is inserted in the cephalo-caudal direction (caliber 21G and length 10 cm) and 3 ml of physiological solution are injected to confirm the injection site: fascial plane between the erector spinae muscle and the large rhomboid, near the tip of the transverse process of T5. Once the correct position of the needle tip has been confirmed, ropivacaine 0.75% 20 ml is injected.
Intercostal nerve block with ropivacaineProcedure or surgery
The intercostal nerve block will be performed by the surgeon at the time of thoracotomy from the 4th to the 8th intercostal space, by injecting 20 ml of 0.75% ropivacaine (4 ml for each space). The injection is performed at about 2-3 cm from the spine.
| Study group | Role | What they receive |
|---|---|---|
| group E | Experimental | patients receiving the ESP block Receives: Procedure: erector spinae plane block with ropivacaine |
| group I | Active comparator | patients receiving the intercostal nerve block Receives: Procedure: Intercostal nerve block with ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
efficacy measured through the evaluation of the NRS score (Numerical Rating Scale) , that ranges from '0' representing one pain extreme (e.g. " no pain") to '10' representing the other pain extreme
Measured: 12 hours from surgery
Secondary outcomes (3)
opioid consumption
the amount of opioid used during the surgical procedure (remifentanil, mcg)
Measured: through surgery completed
function and strength of the respiratory muscle
respiratory pressure meter measuring MIP (maximal inspiratory pressure) and MEP (maximal expiratory pressure)
Measured: 12 hours from the surgery
patient satisfaction about the analgesia technique
Likert satisfaction scale,Satisfaction rate ranged from 5 meaning highly satisfied to 1 meaning highly unsatisfied.
Measured: 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Aug 2019
- Primary completion30 Oct 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- 60 patients will be enrolled to undergo thoracotomy lung resection surgery. The population will be divided into two groups based on the type of block made: Group E: ESP block (n = 30) Group I: Intercostal block (n = 30)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Fiorelli, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013815
- Sponsor's protocol ID
- ESP
- Status last verified
- Mar 2020
- First submitted
- 3 Jul 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Loan WB, Morrison JD. The incidence and severity of postoperative pain. Br J Anaesth. 1967 Sep;39(9):695-8. doi: 10.1093/bja/39.9.695. No abstract available.
PubMed 6051231Sabanathan S, Eng J, Mearns AJ. Alterations in respiratory mechanics following thoracotomy. J R Coll Surg Edinb. 1990 Jun;35(3):144-50.
PubMed 2203902Nunn JF. Effects of anaesthesia on respiration. Br J Anaesth. 1990 Jul;65(1):54-62. doi: 10.1093/bja/65.1.54. No abstract available.
PubMed 2200485Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
PubMed 15763409Sabanathan S, Smith PJ, Pradhan GN, Hashimi H, Eng JB, Mearns AJ. Continuous intercostal nerve block for pain relief after thoracotomy. Ann Thorac Surg. 1988 Oct;46(4):425-6. doi: 10.1016/s0003-4975(10)64657-7.
PubMed 3178353D'Andrilli A, Ibrahim M, Ciccone AM, Venuta F, De Giacomo T, Massullo D, Pinto G, Rendina EA. Intrapleural intercostal nerve block associated with mini-thoracotomy improves pain control after major lung resection. Eur J Cardiothorac Surg. 2006 May;29(5):790-4. doi: 10.1016/j.ejcts.2006.01.002. Epub 2006 Feb 14.
PubMed 16481188Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
PubMed 28919152Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish.
PubMed 29336785Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
PubMed 29913392Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
PubMed 29980005Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.
PubMed 30055991
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Intrapleural Intercostal Plane Block for Post-thoracotomy Pain: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04013815
- Acronym / sponsor ID
- ESP
- Conditions
- Pain, Postoperative
- Keywords
- erector spinae plane block, thoracotomy, ultrasound guided nerve block, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 10 Jul 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.
Post-thoracotomy pain is one of the most severe forms of post-operative pain. Among the most common techniques for the management of post-thoracotomy pain, there are the intercostal nerve block, and a recently described block, the erector spinae plane block (ESP).To date, there are no studies that compare the efficacy of ESP block with other pain relief methods in acute post-thoracotomy pain. The objective of this randomized study is to compare the analgesic efficacy of these two techniques in the control of acute post-thoracotomy chest pain, block of erector spinae vs intrapleural intercostal block.
Detailed description
Post-thoracotomy pain is one of the most severe forms of post-operative pain that can be attributed to muscle incision, rib retraction or resection, and damage to the intercostal nerves. Inadequate control of this post-operative pain can contribute to a deterioration of the respiratory function, with limitation of the ventilation, appearance of atelectasis, ineffective cough, and increased risk of infectious complications. Moreover, recent evidence shows that persistent pain after surgery, in addition to being responsible for chronic post-surgical pain syndrome, is associated with a delay in post-operative recovery and a return to normal daily life activities. The most common techniques for the management of post-thoracotomy pain are in addition to systemic intravenous analgesia, thoracic epidural, paravertebral nerve block and intercostal nerve block. Although the thoracic epidural has been considered for years the gold standard for the control of post-operative pain following thoracotomy, it is not risk-free, requires an expert operator, and can be contraindicated in some categories of patients. The intercostal nerve block, performed through the injection of the local anesthetic in multiple intercostal spaces before performing thoracotomy, may be one of the alternatives to a thoracic epidural in terms of safety and efficacy and is technically easy and quick to perform. This block is found to be particularly effective in reducing post-operative pain when associated with a mini-thoracotomy, helping to improve the outcome of patients undergoing major lung resection. A technique of more recent description (2016) is the erector spinae plane block (ESP) . This interfascial block is performed in the posterior thoracic region homolaterally at the site of the intervention at the level of the T5 transverse process (fifth thoracic vertebra), the ultrasound marker of the block. The ESP block is easy and safe to perform thanks to the ultrasound-guided method and the absence of vascular-nerve structures at risk of damage in the vicinity of the injection site and allows analgesia of the posterior and anterolateral thoracic wall and of the axillary region. In fact, cadaveric studies have shown an anesthetic distribution both in the cranial caudal sense (T2-T8) along the fascia between erector spinae and large rhomboid, and in the anteroposterior direction, with the blockage of the spinal thoracic nerve roots. ESP block was described in the treatment of chronic chest pain in the first place, but was subsequently used as rescue therapy in acute post-thoracotomy pain; it has also been tested in upper abdominal surgery, performed bilaterally. Use in four cases of acute post video thoracoscopy pain management has also been described. Recently, some randomized controlled trials have been carried out that showed: greater analgesic efficacy of ESP compared to intravenous multimodal analgesia standard for the treatment of post-operative pain, with less recourse to rescue doses of morphine following laparoscopic cholecystectomy, mastectomy and cardiac surgery. To date, there are no studies that compare its efficacy with other pain relief methods in acute post-thoracotomy pain. The objective of our study is to compare the analgesic efficacy of these two techniques in the control of acute post-thoracotomy chest pain, blockade of erector spinae vs intrapleural intercostal blockade.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 60 patients will be enrolled to undergo thoracotomy lung resection surgery. The population will be divided into two groups based on the type of block made: Group E: ESP block (n = 30) Group I: Intercostal block (n = 30)
| Arm | Type | Receives |
|---|---|---|
| group E | Experimental | Procedure: erector spinae plane block with ropivacainepatients receiving the ESP block |
| group I | Active comparator | Procedure: Intercostal nerve block with ropivacainepatients receiving the intercostal nerve block |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing thoracotomy lung resection surgery between 45 and 80 years
Key exclusion criteria (5 listed)
- Patients allergic to the drugs used in the study
- Patients with diabetic neuropathy
- Patients with severe hepatic or renal insufficiency
- emergent surgery
- Age <45 years or> 80 years
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 |
|---|---|---|
| erector spinae plane block with ropivacaineThe block is performed immediately before surgery. by an ultrasound guide, with the probe positioned longitudinally, the spinous process of T5 is identified. A peripheral block needle is inserted in the cephalo-caudal direction (caliber 21G and length 10 cm) and 3 ml of physiological solution are injected to confirm the injection site: fascial plane between the erector spinae muscle and the large rhomboid, near the tip of the transverse process of T5. Once the correct position of the needle tip has been confirmed, ropivacaine 0.75% 20 ml is injected. | Procedure or surgery | group E |
| Intercostal nerve block with ropivacaineThe intercostal nerve block will be performed by the surgeon at the time of thoracotomy from the 4th to the 8th intercostal space, by injecting 20 ml of 0.75% ropivacaine (4 ml for each space). The injection is performed at about 2-3 cm from the spine. | Procedure or surgery | group I |
Primary outcome
postoperative pain
Time frame: 12 hours from surgery
efficacy measured through the evaluation of the NRS score (Numerical Rating Scale) , that ranges from '0' representing one pain extreme (e.g. " no pain") to '10' representing the other pain extreme
3 secondary outcomes
opioid consumption
Time frame: through surgery completed
function and strength of the respiratory muscle
Time frame: 12 hours from the surgery
patient satisfaction about the analgesia technique
Time frame: 12 hours after surgery
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 24 Mar 2020.
- Background: PubMed 6051231Loan WB, Morrison JD. The incidence and severity of postoperative pain. Br J Anaesth. 1967 Sep;39(9):695-8. doi: 10.1093/bja/39.9.695. No abstract available.
- Background: PubMed 2203902Sabanathan S, Eng J, Mearns AJ. Alterations in respiratory mechanics following thoracotomy. J R Coll Surg Edinb. 1990 Jun;35(3):144-50.
- Background: PubMed 2200485Nunn JF. Effects of anaesthesia on respiration. Br J Anaesth. 1990 Jul;65(1):54-62. doi: 10.1093/bja/65.1.54. No abstract available.
- Background: PubMed 15763409Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
- Background: PubMed 3178353Sabanathan S, Smith PJ, Pradhan GN, Hashimi H, Eng JB, Mearns AJ. Continuous intercostal nerve block for pain relief after thoracotomy. Ann Thorac Surg. 1988 Oct;46(4):425-6. doi: 10.1016/s0003-4975(10)64657-7.
- Background: PubMed 16481188D'Andrilli A, Ibrahim M, Ciccone AM, Venuta F, De Giacomo T, Massullo D, Pinto G, Rendina EA. Intrapleural intercostal nerve block associated with mini-thoracotomy improves pain control after major lung resection. Eur J Cardiothorac Surg. 2006 May;29(5):790-4. doi: 10.1016/j.ejcts.2006.01.002. Epub 2006 Feb 14.
- Background: PubMed 28919152Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
- Background: PubMed 29336785Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish.
- Background: PubMed 29913392Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
- Background: PubMed 29980005Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
- Background: PubMed 30055991Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinae plane block with ropivacaine and Intercostal nerve block with ropivacaine in people with Pain, Postoperative, run by University of Roma La Sapienza at 1 site in Italy.
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 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 24 Mar 2020. 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 Italy. 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?
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?
postoperative pain (time frame: 12 hours from surgery). 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 NCT04013815, which also lists 11 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 24 Mar 2020.