Postoperative PainPhase 4NCT04567407
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management
A Phase 4 study testing Bilateral erector spinae blocks using ropivacaine in people with Postoperative Pain, run by Boston Children's Hospital at 1 site in United States.
Trial summary
To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for postoperative analgesia in children and adolescents undergoing cardiac surgical procedures via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open label, interventional study. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bilateral erector spinae blocks using ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 22 Jan 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Scheduled as part of the cardiac surgical ERAS program: Patients scheduled for elective surgeries for the following congenital anomalies, or similar: atrial septal defects (all types), partial anomalous pulmonary venous connection (non-obstructed), cor-triatriatum, VSD, partial AV canal, sub-aortic membrane resection, anomalous aortic origin of the coronary arteries, and pulmonary valve/conduit implantation
- Scheduled for a primary sternotomy.
- Ages 2 years through 17 years.
Who cannot join
- Single ventricle physiology.
- Significant scoliosis or other anatomic contraindications to ESB.
- Significant intraoperative hemodynamic instability or bleeding, as ascertained by clinicians taking care of the patient.
- Patients with severe neurodevelopmental delays.
- Patients with previous chronic pain syndromes.
- Patients with a history of greater than 24 hours of postoperative or post-procedural opioid treatment at any point in the 2 months prior to surgery.
- Lack of parental consent and/or child assent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children"S Hospital
Boston, Massachusetts, 02118
About this study
To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for postoperative analgesia in children and adolescents undergoing cardiac surgical procedures via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open label, interventional study.
Read the detailed description
Regional anesthesia-and pediatric regional anesthesia in particular-is a rapidly evolving subfield of anesthesia practice driven with considerable urgency by the growing recognition that even appropriate perioperative opioid administration can have significant deleterious long-term effects.
Regional anesthetics can provide targeted, continuous analgesia to select dermatomes with minimal additional patient risk and as such, have become routine components of opioid-sparing intraoperative and postoperative pain management plans for non-cardiac surgical patients at a single institution. In addition to the postulated benefit of reducing overall opioid exposure (and potentially reducing the risk for long term physiologic and behavioral dependence upon opioids), regional anesthetics may allow for earlier extubation after selected surgeries, shorter intensive care unit (ICU) stays, shorter inpatient admissions, earlier mobilization, fewer gastrointestinal complications, and improved patient and care team satisfaction scores.
Historically, regional anesthetics have been avoided in cardiac surgery as most patients are pharmacologically anticoagulated during their procedures and are thus at increased risk for bleeding. This is particularly worrisome in the pediatric cardiac surgical population as many of these children remain intubated for an extended period of time postoperatively and therefore may not have reliable neurological exams in the setting of neuraxial regional anesthetics-potentially resulting in unrecognized hemorrhage-related acquired neurological deficits.
Recently, the erector spinae block (ESB) has become popular for providing analgesia after a number of anterior chest and abdominal procedures. This simple interfascial plane block can reliably provide unilateral chest and/or abdominal wall analgesia. It has been described in numerous case reports and case series as an effective block for management of unilateral thoracotomies, unilateral rib fractures, unilateral abdominal incisions and most notably, for management of post-sternotomy pain when applied bilaterally. New case reports and series involving the ESB are being published almost weekly with a growing number of manuscripts specific to cardiac surgical applications. Indeed, numerous randomized controlled trials have investigated the analgesic efficacy of bilateral erector spinae plane blocks (BESB) compared with conventional treatment for pain after cardiac surgery in adult patients and have been published recently (2018-2019) with promising results.
As an interfascial plane block in a compressible anatomical space, the ESB is considered safe in anticoagulated (or recently anticoagulated) patients. It is fast becoming a preferred anesthetic option at BCH for anticoagulated patients - as opposed to neuraxial (e.g. epidural) and paraneuraxial blocks (i.e. paravertebral) nerve blocks, which are largely contraindicated in this setting. Further, given its relative ease of placement, apparent efficacy and safety profile, it is increasingly becoming a standard option for patients undergoing a wide range of thoracic, abdominal and thoraco-abdominal procedures.
The investigators recently investigated the feasibility of performing these blocks bilaterally in a pediatric cardiac surgical population undergoing sternotomy-based procedures (IRB-P00031524). At the conclusion of this 10-patient pilot, the investigators found that performing these blocks was technically feasible, requiring 30 minutes or less of OR time, resulting in no known complications. Furthermore, the data suggested an approximate 25% reduction in rescue opioid requirements in the first 48 hours amongst the erector spinae group (p=0.048).
In order to best evaluate the efficacy of this block in the pediatric cardiac population, a blinded, randomized and controlled trial would be ideal. However, given that randomization could be challenging and the fact that blinding would not be feasible, the investigators believe an observational prospective cohort study is most appropriate at this time.
As such, the investigators propose to evaluate the comparative efficacy of BESB versus matched historical controls who received standard of care pain management (systemic opioid therapy) for patients undergoing cardiac surgery via sternotomy by means of a single arm, open label, interventional study that will compare as the primary outcome rescue analgesic requirements, rendered as opiate equivalents, at 12, 24 and 48 hours, and the 24 hour period preceding both 72 and 96 hours postoperatively. 'Efficacy' will be considered as a threshold of clinical significance being defined as a 15% difference). In addition to the primary endpoint, we plan to evaluate the duration of intubation, length of ICU stay, median pain scores, incidence of PONV (postoperative nausea and vomiting; 0-6h, 6-12h and overall), time to mobilization and adverse events between these groups. Postoperative data collected from standard clinical follow-up tools, such as return to baseline sleep and activity status as well as pain medication requirements at home, will also be compared. In addition, the investigators plan to evaluate the quality of sleep and activity with a smart watch (Fitbit™ ) during the perioperative period in the BESB group only.
- Conditions
- Postoperative Pain
- Being tested
- Bilateral erector spinae blocks using ropivacaine
- Keywords
- regional anesthesia, cardiac surgery, erector spinae
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral erector spinae blocks using ropivacaineDrug
Also called Naropin
Bilateral chest wall nerve blocks using ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral erector spinae blocks | Experimental | All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Receives: Drug: Bilateral erector spinae blocks using ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Requirement
Total opiate equivalents
Measured: 24hours postop
Analgesic Requirement
Total opiate equivalents
Measured: 48hours postop
Analgesic Requirement
Total opiate equivalents
Measured: 96hours postop
Secondary outcomes (8)
Duration of Mechanical Ventilation/Intubation
Length of postoperative mechanical ventilation/intubation following OR exit
Measured: 48hrs
Length of Postoperative ICU Stay
Duration of ICU stay following OR exit
Measured: 72Hours
Length of Hospital Stay
Duration of Inpatient hospital admission
Measured: 5 Days
Median Pain Scores
Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.
Measured: day of surgery (POD 0) 7:00am - 18:59pm
Median Pain Scores
Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.
Measured: night of surgery (PON 0) 19:00pm-6:59am
Median Pain Scores
Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.
Measured: Post-Op Day 1 (7:00am-18:59pm)
Median Pain Scores
Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.
Measured: Post-Op Night 1 (19:00pm-6:59am)
Time to First Mobilization
Time to out of bed activity (e.g., up to chair, ambulation)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start22 Sep 2020
- Primary completion22 Jan 2022
- Study completion22 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-arm intervention trial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Brusseau, Boston Children's Hospital
- Investigators
- ROLAND BRUSSEAU, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567407
- Sponsor's protocol ID
- IRB-P00034302
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2020
- Last updated
- 17 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share data.
Publications
Roy N, Parra MF, Brown ML, Sleeper LA, Kossowsky J, Baumer AM, Blitz SE, Booth JM, Higgins CE, Nasr VG, Del Nido PJ, Brusseau R. Erector spinae plane blocks for opioid-sparing multimodal pain management after pediatric cardiac surgery. J Thorac Cardiovasc Surg. 2024 Dec;168(6):1742-1750.e9. doi: 10.1016/j.jtcvs.2024.03.010. Epub 2024 Mar 16.
PubMed 38493959
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management
- ClinicalTrials.gov ID
- NCT04567407
- Acronym / sponsor ID
- IRB-P00034302
- Conditions
- Postoperative Pain
- Keywords
- regional anesthesia, cardiac surgery, erector spinae
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 22 Jan 2022 (actual)
- Study completion
- 22 Jan 2022 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Posted 17 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for postoperative analgesia in children and adolescents undergoing cardiac surgical procedures via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open label, interventional study.
Detailed description
Regional anesthesia-and pediatric regional anesthesia in particular-is a rapidly evolving subfield of anesthesia practice driven with considerable urgency by the growing recognition that even appropriate perioperative opioid administration can have significant deleterious long-term effects.
Regional anesthetics can provide targeted, continuous analgesia to select dermatomes with minimal additional patient risk and as such, have become routine components of opioid-sparing intraoperative and postoperative pain management plans for non-cardiac surgical patients at a single institution. In addition to the postulated benefit of reducing overall opioid exposure (and potentially reducing the risk for long term physiologic and behavioral dependence upon opioids), regional anesthetics may allow for earlier extubation after selected surgeries, shorter intensive care unit (ICU) stays, shorter inpatient admissions, earlier mobilization, fewer gastrointestinal complications, and improved patient and care team satisfaction scores.
Historically, regional anesthetics have been avoided in cardiac surgery as most patients are pharmacologically anticoagulated during their procedures and are thus at increased risk for bleeding. This is particularly worrisome in the pediatric cardiac surgical population as many of these children remain intubated for an extended period of time postoperatively and therefore may not have reliable neurological exams in the setting of neuraxial regional anesthetics-potentially resulting in unrecognized hemorrhage-related acquired neurological deficits.
Recently, the erector spinae block (ESB) has become popular for providing analgesia after a number of anterior chest and abdominal procedures. This simple interfascial plane block can reliably provide unilateral chest and/or abdominal wall analgesia. It has been described in numerous case reports and case series as an effective block for management of unilateral thoracotomies, unilateral rib fractures, unilateral abdominal incisions and most notably, for management of post-sternotomy pain when applied bilaterally. New case reports and series involving the ESB are being published almost weekly with a growing number of manuscripts specific to cardiac surgical applications. Indeed, numerous randomized controlled trials have investigated the analgesic efficacy of bilateral erector spinae plane blocks (BESB) compared with conventional treatment for pain after cardiac surgery in adult patients and have been published recently (2018-2019) with promising results.
As an interfascial plane block in a compressible anatomical space, the ESB is considered safe in anticoagulated (or recently anticoagulated) patients. It is fast becoming a preferred anesthetic option at BCH for anticoagulated patients - as opposed to neuraxial (e.g. epidural) and paraneuraxial blocks (i.e. paravertebral) nerve blocks, which are largely contraindicated in this setting. Further, given its relative ease of placement, apparent efficacy and safety profile, it is increasingly becoming a standard option for patients undergoing a wide range of thoracic, abdominal and thoraco-abdominal procedures.
The investigators recently investigated the feasibility of performing these blocks bilaterally in a pediatric cardiac surgical population undergoing sternotomy-based procedures (IRB-P00031524). At the conclusion of this 10-patient pilot, the investigators found that performing these blocks was technically feasible, requiring 30 minutes or less of OR time, resulting in no known complications. Furthermore, the data suggested an approximate 25% reduction in rescue opioid requirements in the first 48 hours amongst the erector spinae group (p=0.048).
In order to best evaluate the efficacy of this block in the pediatric cardiac population, a blinded, randomized and controlled trial would be ideal. However, given that randomization could be challenging and the fact that blinding would not be feasible, the investigators believe an observational prospective cohort study is most appropriate at this time.
As such, the investigators propose to evaluate the comparative efficacy of BESB versus matched historical controls who received standard of care pain management (systemic opioid therapy) for patients undergoing cardiac surgery via sternotomy by means of a single arm, open label, interventional study that will compare as the primary outcome rescue analgesic requirements, rendered as opiate equivalents, at 12, 24 and 48 hours, and the 24 hour period preceding both 72 and 96 hours postoperatively. 'Efficacy' will be considered as a threshold of clinical significance being defined as a 15% difference). In addition to the primary endpoint, we plan to evaluate the duration of intubation, length of ICU stay, median pain scores, incidence of PONV (postoperative nausea and vomiting; 0-6h, 6-12h and overall), time to mobilization and adverse events between these groups. Postoperative data collected from standard clinical follow-up tools, such as return to baseline sleep and activity status as well as pain medication requirements at home, will also be compared. In addition, the investigators plan to evaluate the quality of sleep and activity with a smart watch (Fitbit™ ) during the perioperative period in the BESB group only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm intervention trial
| Arm | Type | Receives |
|---|---|---|
| Bilateral erector spinae blocks | Experimental | Drug: Bilateral erector spinae blocks using ropivacaineAll enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Scheduled as part of the cardiac surgical ERAS program: Patients scheduled for elective surgeries for the following congenital anomalies, or similar: atrial septal defects (all types), partial anomalous pulmonary venous connection (non-obstructed), cor-triatriatum, VSD, partial AV canal, sub-aortic membrane resection, anomalous aortic origin of the coronary arteries, and pulmonary valve/conduit implantation
- Scheduled for a primary sternotomy.
- Ages 2 years through 17 years.
Key exclusion criteria (7 listed)
- Single ventricle physiology.
- Significant scoliosis or other anatomic contraindications to ESB.
- Significant intraoperative hemodynamic instability or bleeding, as ascertained by clinicians taking care of the patient.
- Patients with severe neurodevelopmental delays.
- Patients with previous chronic pain syndromes.
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 |
|---|---|---|
| Bilateral erector spinae blocks using ropivacaineAlso: NaropinBilateral chest wall nerve blocks using ropivacaine. | Drug | Bilateral erector spinae blocks |
Primary outcome
Analgesic Requirement
Time frame: 24hours postop
Total opiate equivalents
Analgesic Requirement
Time frame: 48hours postop
Total opiate equivalents
Analgesic Requirement
Time frame: 96hours postop
Total opiate equivalents
8 secondary outcomes
Duration of Mechanical Ventilation/Intubation
Time frame: 48hrs
Length of Postoperative ICU Stay
Time frame: 72Hours
Length of Hospital Stay
Time frame: 5 Days
Median Pain Scores
Time frame: day of surgery (POD 0) 7:00am - 18:59pm
Median Pain Scores
Time frame: night of surgery (PON 0) 19:00pm-6:59am
Median Pain Scores
Time frame: Post-Op Day 1 (7:00am-18:59pm)
Median Pain Scores
Time frame: Post-Op Night 1 (19:00pm-6:59am)
Time to First Mobilization
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38493959Roy N, Parra MF, Brown ML, Sleeper LA, Kossowsky J, Baumer AM, Blitz SE, Booth JM, Higgins CE, Nasr VG, Del Nido PJ, Brusseau R. Erector spinae plane blocks for opioid-sparing multimodal pain management after pediatric cardiac surgery. J Thorac Cardiovasc Surg. 2024 Dec;168(6):1742-1750.e9. doi: 10.1016/j.jtcvs.2024.03.010. Epub 2024 Mar 16.
- Individual participant dataSharing planned: No. No current plan to share data.
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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.
ROLAND BRUSSEAU, MD principal investigator
Boston Children's Hospital
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 Bilateral erector spinae blocks using ropivacaine in people with Postoperative Pain, run by Boston Children's Hospital at 1 site in United States.
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 17 Oct 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Analgesic Requirement (time frame: 24hours postop). The study lists 3 primary outcomes in all. 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 NCT04567407, 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 17 Oct 2023.