Abdominal Surgery PatientsLEVO-TAP-PKNCT07581275
Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery
An observational study of Abdominal Surgery Patients and Transversus Abdominis Plane (TAP) Block, run by University of Liege.
Trial summary
This prospective single-center observational pharmacokinetic study will evaluate plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane (TAP) block in adult patients undergoing elective abdominal surgery under general anesthesia at CHU Liège. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Abdominal Surgery Patients, Transversus Abdominis Plane (TAP) Block, Pharmacokinetic Analysis
- What is being tested?
- Ultrasound-Guided Transversus Abdominis Plane Block with Levobupivacaine
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients treated at CHU Liège who are scheduled for elective abdominal surgery under general anesthesia and for whom an ultrasound-guided transversus abdominis plane (TAP) block with levobupivacaine is planned as part of routine perioperative analgesic care. The study population consists of clinically stable surgical patients able to provide informed consent and undergo serial perioperative blood sampling for pharmacokinetic analysis.
Who may be able to join
- Age ≥18 years
- Scheduled elective abdominal surgery under general anesthesia
- Planned ultrasound-guided TAP block as part of standard perioperative analgesic care
- Able to understand and speak French sufficiently to understand the study information and consent form
- Able and willing to provide written informed consent
Who cannot join
- Refusal or inability to provide informed consent
- Known allergy or hypersensitivity to amide local anesthetics
- Severe hepatic impairment
- Renal impairment (estimated glomerular filtration rate <50 mL/min/1.73 m²)
- Contraindication to repeated blood sampling or inability to complete the sampling schedule
- Participation in another clinical study that could affect absorption, distribution, metabolism, or elimination of local anesthetics
Show all 11Show fewer
- Pregnancy
- Emergency surgery or life-threatening urgent condition
- Immediate postoperative instability requiring intensive care transfer (e.g., hemodynamic instability)
- Inability to understand French sufficiently for study information and consent
- Persons requiring special legal protection for consent (e.g., minors, guardianship, incapacity to consent)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery: A Prospective Study and Definition of a Safety Window for Intravenous Lidocaine Administration
This prospective single-center observational pharmacokinetic study will evaluate plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane (TAP) block in adult patients undergoing elective abdominal surgery under general anesthesia at CHU Liège. Participants receiving TAP block as part of standard clinical care (levobupivacaine 0.375%, total volume 40 mL, maximum dose 150 mg) will undergo serial blood sampling at 3, 7, 15, 30, 60, 120, and 180 minutes after block completion. Plasma levobupivacaine concentrations will be measured using validated LC-MS/MS methods. The primary objectives are to estimate maximum plasma concentration (Cmax) and time to maximum concentration (Tmax). Secondary objectives include characterization of the concentration-time profile, AUC0-180, interindividual variability, and exploratory associations with clinical factors (age, sex, BMI, type of surgery). The study also aims to inform a pragmatic safety window for subsequent intravenous lidocaine infusion used in multimodal analgesia protocols. Approximately 26 participants will be enrolled. No modification of routine anesthesia or analgesic care is required apart from study-related blood sampling.
Read the detailed description
This prospective single-center pharmacokinetic observational study is designed to characterize systemic exposure to levobupivacaine after ultrasound-guided transversus abdominis plane (TAP) block performed as part of routine perioperative analgesia for elective abdominal surgery under general anesthesia.
TAP block is widely integrated into multimodal analgesic pathways because it may reduce postoperative pain and opioid requirements. However, administration of relatively large volumes of local anesthetic into fascial planes can result in measurable systemic absorption. Although levobupivacaine has a favorable safety profile compared with racemic bupivacaine, understanding peak plasma concentrations and their timing remains clinically relevant, particularly when additional analgesic strategies such as intravenous lidocaine may be considered during the perioperative period.
Eligible adult participants scheduled for abdominal surgery and already planned to receive TAP block according to institutional practice will be enrolled after informed consent. No changes to standard anesthetic or surgical management are mandated by the study. The TAP block will be performed by experienced anesthesiologists using the institutional standard technique with levobupivacaine 0.375% (total volume 40 mL; maximum dose 150 mg).
The reference time (T0) will be defined as completion of local anesthetic injection. Serial blood samples will be obtained during the early postoperative period at predefined time points up to 180 minutes after T0 to capture the expected absorption phase and early elimination profile. Plasma levobupivacaine concentrations will be quantified using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay.
The primary pharmacokinetic parameters of interest are maximum observed plasma concentration (Cmax) and time to maximum concentration (Tmax). Secondary analyses will include concentration-time profiles, area under the curve from 0 to 180 minutes (AUC0-180), interindividual variability, and exploratory evaluation of associations between exposure metrics and selected demographic or clinical variables such as age, body mass index, sex, and surgical category.
Results are expected to provide real-world pharmacokinetic data for levobupivacaine after TAP block and may help inform safer sequencing of multimodal analgesic approaches, including timing of intravenous lidocaine administration after fascial plane block. Safety monitoring will follow routine perioperative standards, and any suspected local anesthetic systemic toxicity will be managed immediately according to institutional protocols.
- Conditions
- Abdominal Surgery Patients, Transversus Abdominis Plane (TAP) Block, Pharmacokinetic Analysis, Levobupivacaine, Local Anaesthetic Systemic Toxicity
- Being tested
- Ultrasound-Guided Transversus Abdominis Plane Block with Levobupivacaine
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Transversus Abdominis Plane Block with LevobupivacaineProcedure or surgery
Ultrasound-guided transversus abdominis plane (TAP) block performed as part of routine perioperative analgesia after induction of general anesthesia for elective abdominal surgery. Levobupivacaine 0.375% is injected into the transversus abdominis fascial plane under real-time ultrasound visualization, using a total volume of 40 mL (typically bilateral administration, adjusted to surgical indication), with a maximum total dose of 150 mg. The block is performed by an experienced anesthesiologist according to institutional standard practice.
| Study group | Role | What they receive |
|---|---|---|
| TAP Block Pharmacokinetic Cohort | Adult participants undergoing elective abdominal surgery under general anesthesia at CHU Liège who receive an ultrasound-guided transversus abdominis plane (TAP) block with levobupivacaine 0.375% (total volume 40 mL; maximum dose 150 mg) as part of standard perioperative analgesic management. This is a single observational cohort. The intervention of interest is the routine TAP block, after which serial blood samples are collected up to 180 minutes to characterize plasma levobupivacaine pharmacokinetics. No experimental treatment is assigned by the study. Receives: Procedure: Ultrasound-Guided Transversus Abdominis Plane Block with Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Levobupivacaine Concentration (Cmax)
Maximum observed plasma concentration (Cmax, µg/mL) of levobupivacaine after TAP block, determined from serial plasma samples collected during the first 180 minutes after completion of the block.
Measured: From completion of TAP block (T0) to 180 minutes post-block placement
Time to Maximum Plasma Levobupivacaine Concentration (Tmax)
Time to maximum observed plasma concentration (Tmax, minutes) of levobupivacaine after TAP block, determined from serial plasma samples collected during the first 180 minutes after completion of the block.
Measured: From completion of TAP block (T0) to 180 minutes post-block placement
Secondary outcomes (6)
Area Under the Plasma Concentration-Time Curve From 0 to 180 Minutes (AUC0-180) of Levobupivacaine
Area under the plasma concentration-time curve (AUC0-180, µg·min/mL) of levobupivacaine following TAP block, calculated from serial plasma concentration measurements obtained during the first 180 minutes after completion of the block.
Measured: From completion of TAP block (T0) to 180 minutes post-block placement
Plasma Levobupivacaine Concentration at Each Sampling Time Point
Measured plasma concentration (µg/mL) of levobupivacaine at predefined sampling time points after TAP block.
Measured: From completion of TAP block (T0) to 180 minutes post-block placement.
Interindividual Variability of Maximum Plasma Levobupivacaine Concentration (Cmax)
Interindividual variability of maximum plasma levobupivacaine concentration (Cmax), assessed using descriptive dispersion measures including standard deviation and coefficient of variation.
Measured: From completion of TAP block (T0) to 180 minutes post-block placement
Association Between Area Under the Plasma Concentration-Time Curve (AUC0-180) and Clinical Factors
Association between levobupivacaine AUC0-180 (µg·min/mL) and predefined clinical factors including age, sex, body mass index (BMI), and type of surgery.
Measured: From completion of TAP block (T0) to 180 minutes post-block placement
Time to Reach Plasma Levobupivacaine Concentration Below Prespecified Safety Threshold
Time required for plasma levobupivacaine concentrations to decrease below the predefined safety threshold considered compatible with initiation of intravenous lidocaine administration after TAP block.
Measured: From completion of TAP block (T0) to 180 minutes post-block placement
Interindividual Variability of Area Under the Plasma Concentration-Time Curve (AUC0-180)
Interindividual variability of levobupivacaine AUC0-180, assessed using descriptive dispersion measures including standard deviation and coefficient of variation.
Measured: From completion of TAP block (T0) to 180 minutes post-block placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal Surgery PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Carella, University of Liege
- Investigators
- Vincent Bonhomme, MD PhD, Study director, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581275
- Sponsor's protocol ID
- B7072026000035
- Acronym
- LEVO-TAP-PK
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jokinen MJ, Neuvonen PJ, Lindgren L, Hockerstedt K, Sjovall J, Breuer O, Askemark Y, Ahonen J, Olkkola KT. Pharmacokinetics of ropivacaine in patients with chronic end-stage liver disease. Anesthesiology. 2007 Jan;106(1):43-55. doi: 10.1097/00000542-200701000-00011.
PubMed 17197844Mann B, Burch E, Shakeshaft C. Attitudes Toward Acupuncture Among Pain Fellowship Directors. Pain Med. 2016 Mar;17(3):494-500. doi: 10.1093/pm/pnv001. Epub 2015 Dec 7.
PubMed 26814237Atwill ER, Harp JA, Jones T, Jardon PW, Checel S, Zylstra M. Evaluation of periparturient dairy cows and contact surfaces as a reservoir of Cryptosporidium parvum for calfhood infection. Am J Vet Res. 1998 Sep;59(9):1116-21.
PubMed 9736387Yun H, Park M, Lee H, Choi EK. Healthcare Interventions for Children Using Nonimmersive Virtual Reality: A Mixed Methods Systematic Review. J Pediatr Health Care. 2024 Sep-Oct;38(5):703-716. doi: 10.1016/j.pedhc.2024.01.008. Epub 2024 Mar 10.
PubMed 38466243
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery: A Prospective Study and Definition of a Safety Window for Intravenous Lidocaine Administration
- ClinicalTrials.gov ID
- NCT07581275
- Acronym / sponsor ID
- LEVO-TAP-PK / B7072026000035
- Conditions
- Abdominal Surgery Patients, Transversus Abdominis Plane (TAP) Block, Pharmacokinetic Analysis, Levobupivacaine, Local Anaesthetic Systemic Toxicity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 12 May 2026 (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.
This prospective single-center observational pharmacokinetic study will evaluate plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane (TAP) block in adult patients undergoing elective abdominal surgery under general anesthesia at CHU Liège. Participants receiving TAP block as part of standard clinical care (levobupivacaine 0.375%, total volume 40 mL, maximum dose 150 mg) will undergo serial blood sampling at 3, 7, 15, 30, 60, 120, and 180 minutes after block completion. Plasma levobupivacaine concentrations will be measured using validated LC-MS/MS methods. The primary objectives are to estimate maximum plasma concentration (Cmax) and time to maximum concentration (Tmax). Secondary objectives include characterization of the concentration-time profile, AUC0-180, interindividual variability, and exploratory associations with clinical factors (age, sex, BMI, type of surgery). The study also aims to inform a pragmatic safety window for subsequent intravenous lidocaine infusion used in multimodal analgesia protocols. Approximately 26 participants will be enrolled. No modification of routine anesthesia or analgesic care is required apart from study-related blood sampling.
Detailed description
This prospective single-center pharmacokinetic observational study is designed to characterize systemic exposure to levobupivacaine after ultrasound-guided transversus abdominis plane (TAP) block performed as part of routine perioperative analgesia for elective abdominal surgery under general anesthesia.
TAP block is widely integrated into multimodal analgesic pathways because it may reduce postoperative pain and opioid requirements. However, administration of relatively large volumes of local anesthetic into fascial planes can result in measurable systemic absorption. Although levobupivacaine has a favorable safety profile compared with racemic bupivacaine, understanding peak plasma concentrations and their timing remains clinically relevant, particularly when additional analgesic strategies such as intravenous lidocaine may be considered during the perioperative period.
Eligible adult participants scheduled for abdominal surgery and already planned to receive TAP block according to institutional practice will be enrolled after informed consent. No changes to standard anesthetic or surgical management are mandated by the study. The TAP block will be performed by experienced anesthesiologists using the institutional standard technique with levobupivacaine 0.375% (total volume 40 mL; maximum dose 150 mg).
The reference time (T0) will be defined as completion of local anesthetic injection. Serial blood samples will be obtained during the early postoperative period at predefined time points up to 180 minutes after T0 to capture the expected absorption phase and early elimination profile. Plasma levobupivacaine concentrations will be quantified using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay.
The primary pharmacokinetic parameters of interest are maximum observed plasma concentration (Cmax) and time to maximum concentration (Tmax). Secondary analyses will include concentration-time profiles, area under the curve from 0 to 180 minutes (AUC0-180), interindividual variability, and exploratory evaluation of associations between exposure metrics and selected demographic or clinical variables such as age, body mass index, sex, and surgical category.
Results are expected to provide real-world pharmacokinetic data for levobupivacaine after TAP block and may help inform safer sequencing of multimodal analgesic approaches, including timing of intravenous lidocaine administration after fascial plane block. Safety monitoring will follow routine perioperative standards, and any suspected local anesthetic systemic toxicity will be managed immediately according to institutional protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAP Block Pharmacokinetic Cohort | – | Procedure: Ultrasound-Guided Transversus Abdominis Plane Block with LevobupivacaineAdult participants undergoing elective abdominal surgery under general anesthesia at CHU Liège who receive an ultrasound-guided transversus abdominis plane (TAP) block with levobupivacaine 0.375% (total volume 40 mL; maximum dose 150 mg) as part of standard perioperative analgesic management. This is a single observational cohort. The intervention of interest is the routine TAP block, after which serial blood samples are collected up to 180 minutes to characterize plasma levobupivacaine pharmacokinetics. No experimental treatment is assigned by the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated at CHU Liège who are scheduled for elective abdominal surgery under general anesthesia and for whom an ultrasound-guided transversus abdominis plane (TAP) block with levobupivacaine is planned as part of routine perioperative analgesic care. The study population consists of clinically stable surgical patients able to provide informed consent and undergo serial perioperative blood sampling for pharmacokinetic analysis.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Scheduled elective abdominal surgery under general anesthesia
- Planned ultrasound-guided TAP block as part of standard perioperative analgesic care
- Able to understand and speak French sufficiently to understand the study information and consent form
- Able and willing to provide written informed consent
Key exclusion criteria (11 listed)
- Refusal or inability to provide informed consent
- Known allergy or hypersensitivity to amide local anesthetics
- Severe hepatic impairment
- Renal impairment (estimated glomerular filtration rate <50 mL/min/1.73 m²)
- Contraindication to repeated blood sampling or inability to complete the sampling schedule
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 |
|---|---|---|
| Ultrasound-Guided Transversus Abdominis Plane Block with LevobupivacaineUltrasound-guided transversus abdominis plane (TAP) block performed as part of routine perioperative analgesia after induction of general anesthesia for elective abdominal surgery. Levobupivacaine 0.375% is injected into the transversus abdominis fascial plane under real-time ultrasound visualization, using a total volume of 40 mL (typically bilateral administration, adjusted to surgical indication), with a maximum total dose of 150 mg. The block is performed by an experienced anesthesiologist according to institutional standard practice. | Procedure or surgery | TAP Block Pharmacokinetic Cohort |
Primary outcome
Maximum Plasma Levobupivacaine Concentration (Cmax)
Time frame: From completion of TAP block (T0) to 180 minutes post-block placement
Maximum observed plasma concentration (Cmax, µg/mL) of levobupivacaine after TAP block, determined from serial plasma samples collected during the first 180 minutes after completion of the block.
Time to Maximum Plasma Levobupivacaine Concentration (Tmax)
Time frame: From completion of TAP block (T0) to 180 minutes post-block placement
Time to maximum observed plasma concentration (Tmax, minutes) of levobupivacaine after TAP block, determined from serial plasma samples collected during the first 180 minutes after completion of the block.
6 secondary outcomes
Area Under the Plasma Concentration-Time Curve From 0 to 180 Minutes (AUC0-180) of Levobupivacaine
Time frame: From completion of TAP block (T0) to 180 minutes post-block placement
Plasma Levobupivacaine Concentration at Each Sampling Time Point
Time frame: From completion of TAP block (T0) to 180 minutes post-block placement.
Interindividual Variability of Maximum Plasma Levobupivacaine Concentration (Cmax)
Time frame: From completion of TAP block (T0) to 180 minutes post-block placement
Association Between Area Under the Plasma Concentration-Time Curve (AUC0-180) and Clinical Factors
Time frame: From completion of TAP block (T0) to 180 minutes post-block placement
Time to Reach Plasma Levobupivacaine Concentration Below Prespecified Safety Threshold
Time frame: From completion of TAP block (T0) to 180 minutes post-block placement
Interindividual Variability of Area Under the Plasma Concentration-Time Curve (AUC0-180)
Time frame: From completion of TAP block (T0) to 180 minutes post-block placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 17197844Jokinen MJ, Neuvonen PJ, Lindgren L, Hockerstedt K, Sjovall J, Breuer O, Askemark Y, Ahonen J, Olkkola KT. Pharmacokinetics of ropivacaine in patients with chronic end-stage liver disease. Anesthesiology. 2007 Jan;106(1):43-55. doi: 10.1097/00000542-200701000-00011.
- Background: PubMed 26814237Mann B, Burch E, Shakeshaft C. Attitudes Toward Acupuncture Among Pain Fellowship Directors. Pain Med. 2016 Mar;17(3):494-500. doi: 10.1093/pm/pnv001. Epub 2015 Dec 7.
- Background: PubMed 9736387Atwill ER, Harp JA, Jones T, Jardon PW, Checel S, Zylstra M. Evaluation of periparturient dairy cows and contact surfaces as a reservoir of Cryptosporidium parvum for calfhood infection. Am J Vet Res. 1998 Sep;59(9):1116-21.
- Background: PubMed 38466243Yun H, Park M, Lee H, Choi EK. Healthcare Interventions for Children Using Nonimmersive Virtual Reality: A Mixed Methods Systematic Review. J Pediatr Health Care. 2024 Sep-Oct;38(5):703-716. doi: 10.1016/j.pedhc.2024.01.008. Epub 2024 Mar 10.
- Individual participant dataSharing planned: No
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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.
Vincent Bonhomme, MD PhD study director
Centre Hospitalier Universitaire de Liege
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Surgery Patients and Transversus Abdominis Plane (TAP) Block, run by University of Liege.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Carella, MD PhD (+32 4 2843658, mcarella@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Levobupivacaine Concentration (Cmax) (time frame: From completion of TAP block (T0) to 180 minutes post-block placement). The study lists 2 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 NCT07581275, which also lists 4 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 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.