Anesthetics ComplicationsPhase 4NCT04799184
PK/PD Levobupivacaine with and Without Epinephrine After Ultrasound Guided ESP Block
A Phase 4 study testing Levobupivacaine 0.25% with epinephrine 5 ug/ml and Levobupivacaine 0.25% without epinephrine 5 ug/ml in people with Anesthetics Complications and Anesthetic Toxicity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Currently there is no standardized management or single technique to manage postoperative pain after Video-assisted thoracic surgery (VATS), there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia (PCA), peripheral nerve blocks, intercostals, paravertebral… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthetics Complications, Anesthetic Toxicity, Bupivacaine Overdose
- What is being tested?
- Levobupivacaine 0.25% with epinephrine 5 ug/ml and Levobupivacaine 0.25% without epinephrine 5 ug/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChile
- Study dates
- 3 Apr 2019to 9 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of VATS
- ASA I-II
- Body mass index (BMI) 20-34 kg / m2
Who cannot join
- Patients with conversion to thoracotomy
- History of chronic pain
- Drug abuse
- Psychiatric illness
- Allergic to some of the drugs used in the study
- Chronic analgesic users
- History of peripheral neuropathy
- Who refuse the procedure
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 450881
About this study
Official title: Pharmacokinetics and Pharmacodynamics for Levobupivacaine with and Without Epinephrine After Ultrasound Guided Erector Spinae Plane Block
Currently there is no standardized management or single technique to manage postoperative pain after Video-assisted thoracic surgery (VATS), there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia (PCA), peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Erector Spinal Block (ESP), this blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less damage to nerves and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of surgery.
The pharmacokinetic profile that local anesthetics would have when injected into this interfacial compartment has not yet been described, and what the real impact of the use of vasoconstrictor will be in terms of plasma levels and duration of the block.
Our objective is to compare the plasma levels of levobupivacaine achieved after performing an ESP Block with or without epinephrine.
Read the detailed description
Video-assisted thoracic surgery (VATS) is one of the most common procedures performed in thoracic surgery, mainly because it has made it possible to solve many pathologies that previously required a thoracotomy with all the complications that that meant. VATS has been shown to be beneficial for patients, for many reasons such as lower mortality, better postoperative lung function, and shorter stay during hospitalization.
Less invasive procedures such as VATS, where the surgical incision is small and avoids costal resection, produces less postoperative pain when compared to a thoracotomy, this has been objectified by numerous studies that have found lower scores on the numerical verbal scale (NVE) and fewer requirements for pain relievers. Despite the fact that VATS produces less acute postoperative pain (VNS 4-5 on the first postoperative day in VATS vs VNS 6 in thoracotomies), the incidence of chronic postoperative pain ranges from 20 to 47%, which is comparable to thoracotomy, mainly due to damage to the intercostal nerves and inadequate analgesia.
It has been seen that one of the factors associated with the appearance of chronic pain after chest surgery is severe acute pain in the first three postoperative days. Acute pain in VATS is caused by surgical trauma to muscular and bone structures of the thorax, achieving good analgesia is important to maintain adequate respiratory function and avoid complications such as atelectasis, hypoxemia and possible pneumonia.
Currently, there is no standardized management or single technique to manage postoperative pain after VATS, there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia, peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Each of them with advantages and disadvantages, but without being able to demonstrate a clear superiority between them, both the paravertebral and epidural blocks are the ones that accumulate the most reports in the literature regarding the management of postoperative pain, but at the same time they are not exempt from complications such as technical failure, hypotension and difficulty of the procedure. In addition to documenting a low use of thoracic epidurals in VATS.
At the end of 2016, the description of the Erector Spinal Block (ESP) by Forero was published, it blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less nerve damage and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of surgery.
In ESP, the pharmacokinetic (PK) profile that local anesthetics would have when injected into this interfacial compartment has not yet been described, and what will be the real impact of the use of vasoconstrictor in terms of plasma levels and duration of the block.
Considering the above, it is important to know the pharmacodynamics of levobupivacaine after performing an ESP block with ultrasonography in order to know the risks of toxicity from local anesthetics as well as to clinically characterize this block in patients who will undergo VATS.
The first objective of this study is to compare the plasma levels of levobupivacaine achieved after performing an ESP Block with or without epinephrine. As secondary objectives, it is proposed to characterize the block in terms of duration, pain, opioid requirements in the first 24 hours and adverse events, in both groups.
- Conditions
- Anesthetics Complications, Anesthetic Toxicity, Bupivacaine Overdose, Nerve Block, Surgery
- Being tested
- Levobupivacaine 0.25% with epinephrine 5 ug/ml, Levobupivacaine 0.25% without epinephrine 5 ug/ml
- Keywords
- ESP, Perioperative Care, Bupivacaine Overdose, VATS surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine 0.25% with epinephrine 5 ug/mlDrug
Also called ESP, Bupivacaine
The block will be performed under ultrasound vision at T5 level, with the patient seated.
Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% with epinephrine 5 ug / ml until completing a volume of 20 ml in fractional form.
Levobupivacaine 0.25% without epinephrine 5 ug/mlDrug
Also called ESP, Bupivacaine
The block will be performed under ultrasound vision at T5 level, with the patient seated.
Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% without epinephrine 5 ug / ml until completing a volume of 20 ml in fractional form.
| Study group | Role | What they receive |
|---|---|---|
| Group I Epi | Experimental | The ESP will be performed under ultrasound vision at T5 level, with the patient seated.
Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% with epinephrine 5 ug/ml completing a volume of 20 ml. Receives: Drug: Levobupivacaine 0.25% with epinephrine 5 ug/ml |
| Group II no Epi | Active comparator | The ESP will be performed under ultrasound vision at T5 level, with the patient seated.
Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% without epinephrine completing a volume of 20 ml. Receives: Drug: Levobupivacaine 0.25% without epinephrine 5 ug/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of levobupivacaine
Levobupivacaine plasma levels will be measured using High-performance liquid chromatography.
Measured: 5, 10, 20, 30, 60, 90 minutes post block.
Changes in plasma levels levobupivacaine of the group I v/s group II
To assess the changes in plasma levels of the group I with epinephrine versus the group II without epinephrine.
Measured: 5, 10, 20, 30, 60, 90 minutes post block.
Sensitive skin extension
Determine the sensitive skin extension of ESP after its performance using pinprick and temperature discrimination using an alcohol swab.
Measured: 15 minutes post-block
Secondary outcomes (5)
Pain measured
Pain measured by Verbal Numerical Scale (VNS) 0 to 10. 0 = no pain. 10 = worse pain.
Measured: Every 15 minutes per 2 hours in the PACU and 12 hrs, 24 hrs, 48 hrs during hospitalization
Heart Rate
Heart rate (bpm)
Measured: Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Hemodynamics
Invasive arterial pressure (mmHg)
Measured: Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Pulse oximetry
% oximetry saturation
Measured: Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Consumption of morphine or its equivalents
Consumption of morphine or its equivalents (mg/kg/hr)
Measured: During the first 48 hours including intraoperative and postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start3 Apr 2019
- Primary completion1 Aug 2021
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthetics ComplicationsStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into two groups, this will be done through a table of computer-generated random numbers. Group I will receive ESP block with vasoconstrictor and Group II will receive ESP block without vasoconstrictor.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Araneda, MD, Principal investigator, Clinician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799184
- Sponsor's protocol ID
- 170627010
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Procedure performance of ESP in terms of duration and user satisfaction
Publications
Corvetto MA, Echevarria GC, De La Fuente N, Mosqueira L, Solari S, Altermatt FR. Comparison of plasma concentrations of levobupivacaine with and without epinephrine for transversus abdominis plane block. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):633-7. doi: 10.1097/AAP.0b013e31826c330a.
PubMed 23038415Araneda A, De la Cuadra JC, Corvetto M, Balde D, Fuente R, Ibacache M, Contreras V, Solari S, Cortinez I. Pharmacokinetic modelling and simulation for prolonged infusion of levobupivacaine with or without epinephrine in transversus abdominis plane and erector spinae plane blocks: a randomised controlled trial and analysis of pooled data. Br J Anaesth. 2025 Oct;135(4):1051-1058. doi: 10.1016/j.bja.2025.05.047. Epub 2025 Jul 9.
PubMed 40640046
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics for Levobupivacaine with and Without Epinephrine After Ultrasound Guided Erector Spinae Plane Block
- ClinicalTrials.gov ID
- NCT04799184
- Acronym / sponsor ID
- 170627010
- Conditions
- Anesthetics Complications, Anesthetic Toxicity, Bupivacaine Overdose, Nerve Block, Surgery
- Keywords
- ESP, Perioperative Care, Bupivacaine Overdose, VATS surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 16 Mar 2021 (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.
Currently there is no standardized management or single technique to manage postoperative pain after Video-assisted thoracic surgery (VATS), there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia (PCA), peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Erector Spinal Block (ESP), this blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less damage to nerves and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of surgery.
The pharmacokinetic profile that local anesthetics would have when injected into this interfacial compartment has not yet been described, and what the real impact of the use of vasoconstrictor will be in terms of plasma levels and duration of the block.
Our objective is to compare the plasma levels of levobupivacaine achieved after performing an ESP Block with or without epinephrine.
Detailed description
Video-assisted thoracic surgery (VATS) is one of the most common procedures performed in thoracic surgery, mainly because it has made it possible to solve many pathologies that previously required a thoracotomy with all the complications that that meant. VATS has been shown to be beneficial for patients, for many reasons such as lower mortality, better postoperative lung function, and shorter stay during hospitalization.
Less invasive procedures such as VATS, where the surgical incision is small and avoids costal resection, produces less postoperative pain when compared to a thoracotomy, this has been objectified by numerous studies that have found lower scores on the numerical verbal scale (NVE) and fewer requirements for pain relievers. Despite the fact that VATS produces less acute postoperative pain (VNS 4-5 on the first postoperative day in VATS vs VNS 6 in thoracotomies), the incidence of chronic postoperative pain ranges from 20 to 47%, which is comparable to thoracotomy, mainly due to damage to the intercostal nerves and inadequate analgesia.
It has been seen that one of the factors associated with the appearance of chronic pain after chest surgery is severe acute pain in the first three postoperative days. Acute pain in VATS is caused by surgical trauma to muscular and bone structures of the thorax, achieving good analgesia is important to maintain adequate respiratory function and avoid complications such as atelectasis, hypoxemia and possible pneumonia.
Currently, there is no standardized management or single technique to manage postoperative pain after VATS, there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia, peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Each of them with advantages and disadvantages, but without being able to demonstrate a clear superiority between them, both the paravertebral and epidural blocks are the ones that accumulate the most reports in the literature regarding the management of postoperative pain, but at the same time they are not exempt from complications such as technical failure, hypotension and difficulty of the procedure. In addition to documenting a low use of thoracic epidurals in VATS.
At the end of 2016, the description of the Erector Spinal Block (ESP) by Forero was published, it blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less nerve damage and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of surgery.
In ESP, the pharmacokinetic (PK) profile that local anesthetics would have when injected into this interfacial compartment has not yet been described, and what will be the real impact of the use of vasoconstrictor in terms of plasma levels and duration of the block.
Considering the above, it is important to know the pharmacodynamics of levobupivacaine after performing an ESP block with ultrasonography in order to know the risks of toxicity from local anesthetics as well as to clinically characterize this block in patients who will undergo VATS.
The first objective of this study is to compare the plasma levels of levobupivacaine achieved after performing an ESP Block with or without epinephrine. As secondary objectives, it is proposed to characterize the block in terms of duration, pain, opioid requirements in the first 24 hours and adverse events, in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized into two groups, this will be done through a table of computer-generated random numbers. Group I will receive ESP block with vasoconstrictor and Group II will receive ESP block without vasoconstrictor.
| Arm | Type | Receives |
|---|---|---|
| Group I Epi | Experimental | Drug: Levobupivacaine 0.25% with epinephrine 5 ug/mlThe ESP will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% with epinephrine 5 ug/ml completing a volume of 20 ml. |
| Group II no Epi | Active comparator | Drug: Levobupivacaine 0.25% without epinephrine 5 ug/mlThe ESP will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% without epinephrine completing a volume of 20 ml. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication of VATS
- ASA I-II
- Body mass index (BMI) 20-34 kg / m2
Key exclusion criteria (8 listed)
- Patients with conversion to thoracotomy
- History of chronic pain
- Drug abuse
- Psychiatric illness
- Allergic to some of the drugs used in the study
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 |
|---|---|---|
| Levobupivacaine 0.25% with epinephrine 5 ug/mlAlso: ESP, BupivacaineThe block will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% with epinephrine 5 ug / ml until completing a volume of 20 ml in fractional form. | Drug | Group I Epi |
| Levobupivacaine 0.25% without epinephrine 5 ug/mlAlso: ESP, BupivacaineThe block will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% without epinephrine 5 ug / ml until completing a volume of 20 ml in fractional form. | Drug | Group II no Epi |
Primary outcome
Plasma levels of levobupivacaine
Time frame: 5, 10, 20, 30, 60, 90 minutes post block.
Levobupivacaine plasma levels will be measured using High-performance liquid chromatography.
Changes in plasma levels levobupivacaine of the group I v/s group II
Time frame: 5, 10, 20, 30, 60, 90 minutes post block.
To assess the changes in plasma levels of the group I with epinephrine versus the group II without epinephrine.
Sensitive skin extension
Time frame: 15 minutes post-block
Determine the sensitive skin extension of ESP after its performance using pinprick and temperature discrimination using an alcohol swab.
5 secondary outcomes
Pain measured
Time frame: Every 15 minutes per 2 hours in the PACU and 12 hrs, 24 hrs, 48 hrs during hospitalization
Heart Rate
Time frame: Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Hemodynamics
Time frame: Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Pulse oximetry
Time frame: Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Consumption of morphine or its equivalents
Time frame: During the first 48 hours including intraoperative and postoperative
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 Mar 2025.
- Background: PubMed 23038415Corvetto MA, Echevarria GC, De La Fuente N, Mosqueira L, Solari S, Altermatt FR. Comparison of plasma concentrations of levobupivacaine with and without epinephrine for transversus abdominis plane block. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):633-7. doi: 10.1097/AAP.0b013e31826c330a.
- Derived from this study: PubMed 40640046Araneda A, De la Cuadra JC, Corvetto M, Balde D, Fuente R, Ibacache M, Contreras V, Solari S, Cortinez I. Pharmacokinetic modelling and simulation for prolonged infusion of levobupivacaine with or without epinephrine in transversus abdominis plane and erector spinae plane blocks: a randomised controlled trial and analysis of pooled data. Br J Anaesth. 2025 Oct;135(4):1051-1058. doi: 10.1016/j.bja.2025.05.047. Epub 2025 Jul 9.
- Individual participant dataSharing planned: Yes. Procedure performance of ESP in terms of duration and user satisfaction
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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.
Andrea Araneda, MD principal investigator
Clinician
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 Levobupivacaine 0.25% with epinephrine 5 ug/ml and Levobupivacaine 0.25% without epinephrine 5 ug/ml in people with Anesthetics Complications and Anesthetic Toxicity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 8 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 Mar 2025. 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 Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of levobupivacaine (time frame: 5, 10, 20, 30, 60, 90 minutes post block.). 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 NCT04799184, which also lists 2 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 Mar 2025.