CholecystitisNCT06656299
EOIB for Laparoscopic Cholecystectomy
A study testing ultrasound guided external oblique intercostal plane block, Bupivacaine injection and paracetamol, tramadol, and ondansetron in people with Cholecystitis and Cholecystitis, Acute, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy, while less painful compared to conventional methods, is still a surgery that can cause significant pain for patients. Preventing postoperative pain is crucial for reducing respiratory complications, shortening hospital stays, and increasing patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholecystitis, Cholecystitis, Acute, Cholecystitis, Chronic
- What is being tested?
- ultrasound guided external oblique intercostal plane block, Bupivacaine injection and paracetamol, tramadol, and ondansetron
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2024to 1 Nov 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 who will be scheduled for an elective laparoscopic cholecystectomy under general anesthesia
- ASA (American Society of Anesthesiologists) I-II-III
Who cannot join
- presence of coagulation disorder
- infection at the injection site of the block
- known allergy to local anesthetics
- advanced hepatic, heart or renal failure
- history of abdominal surgery or trauma
- conversion of laparoscopic to open surgery
Show all 13Show fewer
- consumption of any pain killers within the 24 h before the operation
- chronic opioid consumption
- pregnancy
- alcohol or drug abuse
- body mass index (BMI) ≥ 35 kg m-2
- Impairment of the patient's cognitive functions (such as Alzheimer's disease, dementia, etc.).
- Cholecystectomy cases performed under emergency conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul
Mehmet Cihangir Ağca, Medical Doctor, +905367959178, mehmetcihangiragca@gmail.com
About this study
Official title: Evaluation of Post-Operative Analgesic Efficacy of Bilateral External Oblique Intercostal Plane Block Versus Wound Site Infiltration Control Group in Patients Underwent Laparoscopic Cholecystectomy Surgery
Laparoscopic cholecystectomy, while less painful compared to conventional methods, is still a surgery that can cause significant pain for patients. Preventing postoperative pain is crucial for reducing respiratory complications, shortening hospital stays, and increasing patient satisfaction. Interfascial plane blocks have been widely used for postoperative analgesia in recent years worldwide. The External Oblique Intercostal Plane Block is one of the interfascial plane blocks used in abdominal surgeries. In our study, we aimed to compare the postoperative pain scores of patients who underwent laparoscopic cholecystectomy under general anesthesia, specifically between those who received the external oblique intercostal plane block and those who had trocar entry site infiltration.
Read the detailed description
Despite the advancements in surgical and anesthesia techniques, pain following surgical interventions remains a significant issue concerning patient health and comfort today. The physiological response resulting from surgical trauma and stress can lead to various unwanted conditions in the pulmonary, cardiovascular, gastrointestinal, metabolic, and neuroendocrine systems. These complications negatively impact wound healing, length of hospital stay, and costs. The primary goal in managing pain after surgery is to facilitate the healing process, avoid potential side effects associated with analgesic treatments, and enhance patient comfort.
Cholecystectomy, which plays a significant role among abdominal surgical interventions, can currently be performed using two distinct techniques: open and laparoscopic.
Laparoscopic cholecystectomy is considered the gold standard treatment for symptomatic cholelithiasis due to its ability to cause less trauma compared to open surgery, facilitate faster recovery in patients, result in less postoperative pain, and allow patients to return to their normal lives more quickly.
There are three components of postoperative pain observed after laparoscopic cholecystectomy. These include somatic pain associated with the laparoscopic trocar entry incisions in the anterior abdominal wall, visceral pain due to pneumoperitoneum and surgical dissection of the gallbladder, and referred shoulder pain resulting from the stimulation of the phrenic nerve by residual carbon dioxide gas.
Effective management of postoperative pain is crucial for reducing respiratory complications, shortening hospital stay, and increasing patient satisfaction. In this context, both nonsteroidal intravenous analgesics and opioids are used. However, opioids have undesirable side effects, including respiratory depression, nausea and vomiting, and reduced gastrointestinal motility. Therefore, multimodal analgesia methods that combine intravenous analgesics with regional anesthesia are preferred, allowing for the reduction of drug-related side effects while providing safe and effective postoperative analgesia.
Interfascial plane blocks have been widely used for postoperative analgesia worldwide in recent years. When using long-acting local anesthetics and performed under ultrasound guidance, peripheral nerve blocks can be administered more easily, effectively, and reliably, providing analgesia for approximately 8 to 24 hours.
The External Oblique Intercostal Plane Block (EOIB) is one of the interfascial blocks used in upper abdominal surgeries. The local anesthetic is administered between the anterior axillary line and the midclavicular line, specifically in the fascia between the external oblique muscle and the sixth rib. Cadaver studies have demonstrated the spread of local anesthesia to the anterior cutaneous nerve at the T6-9 dermatomes and to the lateral cutaneous nerve at the T6-10 dermatomes. These studies suggest that the EOIB could be part of multimodal analgesia in upper and lateral abdominal surgeries. In this study, our hypothesis is that the EOIB may reduce the amount of opioids used in postoperative pain management, decrease opioid-related side effects, enhance patient comfort, and shorten the recovery process.
- Being tested
- ultrasound guided external oblique intercostal plane block, Bupivacaine injection, paracetamol, tramadol, and ondansetron
- Keywords
- External Oblique Intercostal Plan Block, Wound Infiltration, Laparoscopic Cholecystectomy, Postoperative pain
- Medical subject headings
- Cholecystitis, Cholecystitis, Acute, Bronchiolitis Obliterans Syndrome, Gallstones, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided external oblique intercostal plane blockDevice
ultrasound guided external oblique intercostal plane block
Bupivacaine injectionDrug
Also called Local anesthetic injection
5 ml local anesthetic for each trocar sides
paracetamol, tramadol, and ondansetronDrug
As standard multimodal analgesia, 20 min before the end of the surgery patients will receive 1 g of paracetamol, 1-2 mg/kg of tramadol, and 4 mg of ondansetron via intravenous infusion.
All patients will be recovered in the PACU, and after confirming an Aldrete score of >9, a PCA (patient-controlled analgesia) device will be installed with morphine prepared at a dose appropriate for the patient's age. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. When patients have a Numerical Rating Scale (NRS) score is ≥ 4, 1 mg/kg iv tramadol will be administered as a rescue analgesic
| Study group | Role | What they receive |
|---|---|---|
| Grup E (External Oblique Intercostal Plane Block) | Active comparator | At the end of the surgical procedure,a high-frequency linear probe will be sterilely covered,and an 80mm block needle will be used for the procedure.Under sterile conditions,the ultrasound probe will be placed in a parasagittal position in the area between the anterior axillary line and the midclavicular line at the level of the 10th rib, and then slid cranially along the longitudinal axis to the level of the 6th and 7th ribs. After visualizing the external oblique muscle, the block needle will be inserted using an in-plane technique,and 5ml of saline will be administered to confirm the location at the external oblique intercostal plane between the external oblique muscle and the 6th rib. Once the location is confirmed, 20cc of 0.25%bupivacaine will be infiltrated into the EOIP. The same procedure will be applied to the opposite side (totally 40 ml). Receives: Device: ultrasound guided external oblique intercostal plane block; Drug: paracetamol, tramadol, and ondansetron |
| Grup T ( Trocar entry site infiltration) | Other | After the trocar removed during the surgical procedure, the surgeon will administer 5 ml of 0.25% bupivacaine infiltration to each trocar entry site. Receives: Drug: Bupivacaine injection; Drug: paracetamol, tramadol, and ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (Numeric Rating Skore)
The primary outcome variable is Numerical Rating Scale scores both at rest and motion. A blinded anesthesiologist will assess postoperative pain during rest and motion at the postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).
Measured: Postoperative 24 hours
Secondary outcomes (5)
Opioid Consumption
First 24 hours total morphine consumption with patient controlled analgesia
Measured: Postoperative 24 hours
Time to first rescue analgesic
The time for administration of first rescue analgesic.
Measured: Postoperative 24 hours
Adverse Events
Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.
Measured: Postoperative 24 hours
Metoclopromide Consumption
The severity of the nausea will be assessed on a 4 -point scale (0=none 1=mild, 2=moderate 3=severe). If the patients nausea score is ≥2 the patient will receive 10 mg metoclopromide.
Measured: Postoperative 24 hours
Quality of recovery levels between groups by using QoR-15 questionnaire
A 15-parameter Quality of Recovery score (QoR-15) has been recommended as the optimum tool to evaluate overall patient-centers measures of recovery after surgery, including pain. It is a questionnaire that is given to patients to do postoperatively and is scored from 0 to 150 where 150 indicates that the patient has had an excellent recovery QoR-15 score will be recorded on the morning of operation and at the postoperative 24th hour
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start30 Oct 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholecystitisStudies 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
- There are two groups for this study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656299
- Sponsor's protocol ID
- EOIB
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD
Publications
Korkusuz M, Basaran B, Et T, Bilge A, Yarimoglu R, Yildirim H. Bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. Saudi Med J. 2023 Oct;44(10):1037-1046. doi: 10.15537/smj.2023.44.10.20230350.
PubMed 37777270Doymus O, Ahiskalioglu A, Kaciroglu A, Bedir Z, Tayar S, Yeni M, Karadeniz E. External Oblique Intercostal Plane Block Versus Port-Site Infiltration for Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Study. Obes Surg. 2024 May;34(5):1826-1833. doi: 10.1007/s11695-024-07219-z. Epub 2024 Apr 2.
PubMed 38565828Mehmet Selim C, Halide S, Erkan Cem C, Onur K, Sedat H, Senem U. Efficacy of Unilateral External Oblique Intercostal Fascial Plane Block Versus Subcostal TAP Block in Laparoscopic Cholecystectomy: Randomized, Prospective Study. Surg Innov. 2024 Aug;31(4):381-388. doi: 10.1177/15533506241256529. Epub 2024 May 23.
PubMed 38780355
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-Operative Analgesic Efficacy of Bilateral External Oblique Intercostal Plane Block Versus Wound Site Infiltration Control Group in Patients Underwent Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT06656299
- Acronym / sponsor ID
- EOIB
- Keywords
- External Oblique Intercostal Plan Block, Wound Infiltration, Laparoscopic Cholecystectomy, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 24 Oct 2024 (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.
Laparoscopic cholecystectomy, while less painful compared to conventional methods, is still a surgery that can cause significant pain for patients. Preventing postoperative pain is crucial for reducing respiratory complications, shortening hospital stays, and increasing patient satisfaction. Interfascial plane blocks have been widely used for postoperative analgesia in recent years worldwide. The External Oblique Intercostal Plane Block is one of the interfascial plane blocks used in abdominal surgeries. In our study, we aimed to compare the postoperative pain scores of patients who underwent laparoscopic cholecystectomy under general anesthesia, specifically between those who received the external oblique intercostal plane block and those who had trocar entry site infiltration.
Detailed description
Despite the advancements in surgical and anesthesia techniques, pain following surgical interventions remains a significant issue concerning patient health and comfort today. The physiological response resulting from surgical trauma and stress can lead to various unwanted conditions in the pulmonary, cardiovascular, gastrointestinal, metabolic, and neuroendocrine systems. These complications negatively impact wound healing, length of hospital stay, and costs. The primary goal in managing pain after surgery is to facilitate the healing process, avoid potential side effects associated with analgesic treatments, and enhance patient comfort.
Cholecystectomy, which plays a significant role among abdominal surgical interventions, can currently be performed using two distinct techniques: open and laparoscopic.
Laparoscopic cholecystectomy is considered the gold standard treatment for symptomatic cholelithiasis due to its ability to cause less trauma compared to open surgery, facilitate faster recovery in patients, result in less postoperative pain, and allow patients to return to their normal lives more quickly.
There are three components of postoperative pain observed after laparoscopic cholecystectomy. These include somatic pain associated with the laparoscopic trocar entry incisions in the anterior abdominal wall, visceral pain due to pneumoperitoneum and surgical dissection of the gallbladder, and referred shoulder pain resulting from the stimulation of the phrenic nerve by residual carbon dioxide gas.
Effective management of postoperative pain is crucial for reducing respiratory complications, shortening hospital stay, and increasing patient satisfaction. In this context, both nonsteroidal intravenous analgesics and opioids are used. However, opioids have undesirable side effects, including respiratory depression, nausea and vomiting, and reduced gastrointestinal motility. Therefore, multimodal analgesia methods that combine intravenous analgesics with regional anesthesia are preferred, allowing for the reduction of drug-related side effects while providing safe and effective postoperative analgesia.
Interfascial plane blocks have been widely used for postoperative analgesia worldwide in recent years. When using long-acting local anesthetics and performed under ultrasound guidance, peripheral nerve blocks can be administered more easily, effectively, and reliably, providing analgesia for approximately 8 to 24 hours.
The External Oblique Intercostal Plane Block (EOIB) is one of the interfascial blocks used in upper abdominal surgeries. The local anesthetic is administered between the anterior axillary line and the midclavicular line, specifically in the fascia between the external oblique muscle and the sixth rib. Cadaver studies have demonstrated the spread of local anesthesia to the anterior cutaneous nerve at the T6-9 dermatomes and to the lateral cutaneous nerve at the T6-10 dermatomes. These studies suggest that the EOIB could be part of multimodal analgesia in upper and lateral abdominal surgeries. In this study, our hypothesis is that the EOIB may reduce the amount of opioids used in postoperative pain management, decrease opioid-related side effects, enhance patient comfort, and shorten the recovery process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two groups for this study
| Arm | Type | Receives |
|---|---|---|
| Grup E (External Oblique Intercostal Plane Block) | Active comparator | Device: ultrasound guided external oblique intercostal plane block, Drug: paracetamol, tramadol, and ondansetronAt the end of the surgical procedure,a high-frequency linear probe will be sterilely covered,and an 80mm block needle will be used for the procedure.Under sterile conditions,the ultrasound probe will be placed in a parasagittal position in the area between the anterior axillary line and the midclavicular line at the level of the 10th rib, and then slid cranially along the longitudinal axis to the level of the 6th and 7th ribs. After visualizing the external oblique muscle, the block needle will be inserted using an in-plane technique,and 5ml of saline will be administered to confirm the location at the external oblique intercostal plane between the external oblique muscle and the 6th rib. Once the location is confirmed, 20cc of 0.25%bupivacaine will be infiltrated into the EOIP. The same procedure will be applied to the opposite side (totally 40 ml). |
| Grup T ( Trocar entry site infiltration) | Other | Drug: Bupivacaine injection, Drug: paracetamol, tramadol, and ondansetronAfter the trocar removed during the surgical procedure, the surgeon will administer 5 ml of 0.25% bupivacaine infiltration to each trocar entry site. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 65 who will be scheduled for an elective laparoscopic cholecystectomy under general anesthesia
- ASA (American Society of Anesthesiologists) I-II-III
Key exclusion criteria (13 listed)
- presence of coagulation disorder
- infection at the injection site of the block
- known allergy to local anesthetics
- advanced hepatic, heart or renal failure
- history of abdominal surgery or trauma
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 external oblique intercostal plane blockultrasound guided external oblique intercostal plane block | Device | Grup E (External Oblique Intercostal Plane Block) |
| Bupivacaine injectionAlso: Local anesthetic injection5 ml local anesthetic for each trocar sides | Drug | Grup T ( Trocar entry site infiltration) |
| paracetamol, tramadol, and ondansetronAs standard multimodal analgesia, 20 min before the end of the surgery patients will receive 1 g of paracetamol, 1-2 mg/kg of tramadol, and 4 mg of ondansetron via intravenous infusion. All patients will be recovered in the PACU, and after confirming an Aldrete score of >9, a PCA (patient-controlled analgesia) device will be installed with morphine prepared at a dose appropriate for the patient's age. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. When patients have a Numerical Rating Scale (NRS) score is ≥ 4, 1 mg/kg iv tramadol will be administered as a rescue analgesic | Drug | Grup E (External Oblique Intercostal Plane Block), Grup T ( Trocar entry site infiltration) |
Primary outcome
NRS (Numeric Rating Skore)
Time frame: Postoperative 24 hours
The primary outcome variable is Numerical Rating Scale scores both at rest and motion. A blinded anesthesiologist will assess postoperative pain during rest and motion at the postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).
5 secondary outcomes
Opioid Consumption
Time frame: Postoperative 24 hours
Time to first rescue analgesic
Time frame: Postoperative 24 hours
Adverse Events
Time frame: Postoperative 24 hours
Metoclopromide Consumption
Time frame: Postoperative 24 hours
Quality of recovery levels between groups by using QoR-15 questionnaire
Time frame: Postoperative 24 hours
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 1 Nov 2024.
- Background: PubMed 37777270Korkusuz M, Basaran B, Et T, Bilge A, Yarimoglu R, Yildirim H. Bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. Saudi Med J. 2023 Oct;44(10):1037-1046. doi: 10.15537/smj.2023.44.10.20230350.
- Background: PubMed 38565828Doymus O, Ahiskalioglu A, Kaciroglu A, Bedir Z, Tayar S, Yeni M, Karadeniz E. External Oblique Intercostal Plane Block Versus Port-Site Infiltration for Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Study. Obes Surg. 2024 May;34(5):1826-1833. doi: 10.1007/s11695-024-07219-z. Epub 2024 Apr 2.
- Background: PubMed 38780355Mehmet Selim C, Halide S, Erkan Cem C, Onur K, Sedat H, Senem U. Efficacy of Unilateral External Oblique Intercostal Fascial Plane Block Versus Subcostal TAP Block in Laparoscopic Cholecystectomy: Randomized, Prospective Study. Surg Innov. 2024 Aug;31(4):381-388. doi: 10.1177/15533506241256529. Epub 2024 May 23.
- Individual participant dataSharing planned: No. We will not share IPD
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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.
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided external oblique intercostal plane block, Bupivacaine injection and paracetamol, tramadol, and ondansetron in people with Cholecystitis and Cholecystitis, Acute, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 1 Nov 2024. 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 Turkey (Türkiye). 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (Numeric Rating Skore) (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06656299, which also lists 3 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 1 Nov 2024.