PainNCT06136000
S-ESP and Ring Block in Circümcision Surgery (S-ESP: Sacral Erectör Spinae Plane Block).
A study testing Sacral erectör spinae plane block and Ring Block in people with Pain and Pain, Postoperative, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although it is not known exactly when and where circumcision was first performed, it is claimed that it was first performed by the Egyptians, according to various beliefs and traditions. Read more about this study
- Who is it for?
- Ages 4 to 16 years, men only
- Conditions the study is for
- Pain, Pain, Postoperative
- What is being tested?
- Sacral erectör spinae plane block and Ring Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2023to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- patients between the ages of 4-16
- patients with ASA I-II.
- Patients who will receive general anesthesia
Who cannot join
- Parents and patients who do not want to give consent
- Patients with ASAIII and above
- Patients with a disordered bleeding profile
- Patients using anticoagulants
- Patients with infection in the area to be treated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sacral Circumcision Surgery: Comparison of the Effects of Erector Spina Plane Block and Ring Block on Postoperative Pain
Although it is not known exactly when and where circumcision was first performed, it is claimed that it was first performed by the Egyptians, according to various beliefs and traditions. Circumcision is the surgical removal of the skin surrounding the glans penis in pediatric male patients and is the most commonly performed surgery in boys (4). Because the foreskin is sensitive and the pain threshold is low, patients experience severe pain in the postoperative period. Various analgesic methods have been developed to reduce this pain. Sacral surgery has started to be used in adult patients in recent years, but there is not enough information about its application in pediatric patients. Sacral erector spinae plane block is on the agenda. While sacral erectör spinae plane block was first applied in gender reassignment and pilonidal sinus surgery in adults, it was also applied to a small extent in hypospadias and anoplasty surgery in pediatric patients. In some studies, circumcision surgery involves the root and distal parts of the penis. It has been emphasized that ring blocks applied with anesthesia also have an analgesic effect. Our aim in this study was to compare the effect of S-ESPB and ring block on postoperative Face, Legs, Movement, Crying, Avocative Behavioral Scale pain scores in pediatric patients undergoing circumcision surgery and to compare the number of patients who required rescue analgesia, the time until the first rescue analgesia, possible complications, and parental satisfaction (a Likert scale will be used).
In this study, we found that sacral erectör spinae plane block is different from the ring block applied in routine practice in circumcision surgery. We think that postoperative analgesic effectiveness will be higher.
Our aim in this study was to compare the effect of sacral erectör spinae plane block and ring block on postoperative Face, Legs, Movement, Crying, Avocative Behavioral Scale pain score in pediatric patients undergoing circumcision surgery and to compare the number of patients who required rescue analgesia secondarily, the time until the first rescue analgesia, possible complications and parental satisfaction (Likert scale will be used).
Read the detailed description
Our primary hypothesis erectör spinae plane block will be effective in pediatric patients undergoing circumcision surgery. The effect on postoperative pain will be greater than the applied ring block and the Face, Legs, Movement, Crying, Avocative Behavioral Scale pain score will be lower.
Our secondary hypothesis is that the number of patients requiring rescue analgesia and the complications that may occur will be lower in sacral erectör spinae plane block to be applied in circumcision surgery compared to the ring block, and parental satisfaction and the time until the first rescue analgesia will be higher.
Material oath methods: Our study will be carried out within 6 months with 50 patients in the operating room of Konya City Hospital of the University of Health Sciences and the operating room of Harran University Faculty of Medicine Randomization This study was a multicenter prospective study. It was planned and will be carried out as a randomized study. Randomization will be carried out by the sealed envelope method. Patients will be divided into two groups: Group R (patients who underwent Ring block) and Group S (patients who underwent sacral erectör spinae plane block). Since it is a multicenter study, the anesthesia technique will be applied by two different physicians with at least five years of clinical experience and the postoperative results will be recorded by 2 different physicians. These physicians will evaluate patients completely independently and blindly. Written and verbal consent will be obtained from the patient's parents.
Anesthesia Technique and Analgesia Protocol:
Routine anesthesia monitoring and method will be applied to all patients. 22 gauge to patients Intravenous ( IV ) cannulation is provided and 15cc/kg/ h Isotonic fluid will be started. General anesthesia induction 1mg midazolam IV, 2 mg/kg propofol IV, and 1 mcg /kg remifentanil It will be done by giving IV. The patients will be fitted with a laryngeal mask airway (LMA), which we use in routine practice, and will require minimum anesthesia maintenance. alveolar Sevoflurane will be given with a concentration (MAC) value of 1. Before the surgical procedure begins, sacral erectör spinae plane block will be applied to the patients by the anesthesiologist or ring block by the pediatric surgeon. Then circumcision surgery will begin. The same surgical method will be applied to all patients.
At the end of the surgery, we routinely administer 15 mg/kg IV to all patients. Paracetamol will be given. Extubated patients will be transferred to the postanesthetic care unit (PACU) for observation. 0-1-2-4-6 from the time patients are admitted to the PACU until they are discharged from the hospital. Pain levels will be evaluated with the Face, Legs, Movement, Crying, Avocative Behavioral Scale pain scale. Patients with a Face, Legs, Movement, Crying, Avocative Behavioral Scale score of 4 and above will be given 10 mg/kg oral ibuprofen rescue analgesia. The number of patients requiring rescue analgesia, the time until the first rescue analgesia, complications that will develop, and parental satisfaction will be recorded.
sacral erectör spinae plane block with ultrasound guidance Group S will be placed on their side. Asepsis is fifth in the transverse plane under antisepsis standards. high-frequency [(10-15 millihertz ( mHz )] linear ultrasonography probe into the spinous process The ultrasonography probe will be shifted caudally to visualize the first and second median sacral crest. The USG probe is then placed on the second medial It will be placed 3-4 cm lateral to the sacral apex and the mid-sacral apex will be imaged. On the ultrasonography screen, from top to bottom, erector spinae muscle, multifidus muscle and sacral intermediate The crest will be displayed. 0.25% bupivacaine will be administered in a total volume of 0.5ml/kg (maximum 20 cc ) by applying negative aspiration with the in-plane technique with a 50 mm Stimuplex A needle. The process will be applied bilaterally.
Ring Block It is a block that is routinely performed in our clinic by a pediatric surgeon. The patient is under general anesthesia. Before the surgical procedure begins, the pediatric surgeon administers 0.5ml/kg (maximum 20cc) 0.25% bupivacaine to the base of the root of the penis with a 25-gauge needle at 3, 6, 9, and 12 o'clock. local It will be administered under anesthesia.
Primary evaluation criteria are the Face, Legs, Movement, Crying, Avocative Behavioral Scale of pain at rest and movement at 0, 1, 2, 4, and 6 hours after surgery (0-10, 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7- It will be evaluated with 10 = the most severe pain).
Secondary evaluation criteria are the number of patients needing rescue analgesia, the time until the first rescue analgesia, the complications that will develop, and parental satisfaction. The age, weight, height, and surgery duration of the patients in both groups were recorded. Likert evaluation test will be applied for parental satisfaction.
Sample Size:
for circumcision under general anesthesia. patients who will undergo surgery. In the sample size analysis, it was determined that there should be 19 patients for each group with a 95% power rate and an alpha margin of error of 0.05 for comparison of the two groups. The effect used for this calculation is 1.106, based on similar studies, actual power was calculated as 0.955. As a result of the analysis, drop Considering the out rate, it was planned to recruit 25 patients for each group (50 patients in total).
Statistical Analyzes To determine whether the data is normally distributed, the Shapiro Wilks test will be used. Descriptive statistical analyses will be used to evaluate demographic data and data obtained from tests and scales. A paired sample T-test will be used to compare data. Correlation analysis will be used to evaluate the relationship between data. Data will be expressed as mean ± standard deviation and percentage. P <0.05 will be considered statistically significant. In correlation analysis, confidence intervals and p-values will be evaluated according to whether they show a statistically significant or non-significant inverse interaction.
- Conditions
- Pain, Pain, Postoperative
- Being tested
- Sacral erectör spinae plane block, Ring Block
- Keywords
- erectör spinae plane block, ring block, postoperative analgesia
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral erectör spinae plane blockOther
Group S will be placed on their side. Asepsis is fifth in the transverse plane under antisepsis standards. high-frequency linear USG probe into the spinous process . The USG probe will be shifted caudally to visualize the first and second median sacral crest. The USG probe is then placed on the second medial It will be placed 3-4 cm lateral to the sacral apex and the mid-sacral apex will be imaged. On the USG screen, from top to bottom, erector spinae muscle, multifidus muscle and sacral intermediate The crest will be displayed. 0.25% bupivacaine will be administered in a total volume of 0.5ml/kg (maximum 20 cc ) by applying negative aspiration with the in-plane technique with a 50 mm Stimuplex A needle.
Ring BlockOther
The patient is under general anesthesia. Before the surgical procedure begins, the pediatric surgeon administers 0.5ml/kg (maximum 20cc) 0.25% bupivacaine to the base of the root of the penis with a 25-gauge needle at 3, 6, 9, and 12 o'clock.
| Study group | Role | What they receive |
|---|---|---|
| SACRAL EREKTÖR SPİNAE PLANE BLOK | Active comparator | Not described Receives: Other: Sacral erectör spinae plane block |
| RİNG BLOCK | Active comparator | Not described Receives: Other: Ring Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face, Legs, Movement, Crying, Avocative Behavioral Scale
Primary evaluation criteria are the Face, Legs, Movement, Crying, Avocative Behavioral Scaleof pain at rest and movement at 0, 1, 2, 4, and 6 hours after surgery (0-10, 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7- It will be evaluated with 10 = the most severe pain).
Measured: FİVE MONTHS
Secondary outcomes (1)
Postoperative rescue analgesia
Secondary evaluation criteria are The number of patients needing rescue analgesia, the time until the first rescue analgesia, the complications that will develop, and parental satisfaction. The age, weight (kilogram), height (centimeter) and surgery duration of the patients in both groups were recorded. Likert evaluation test will be applied for parental satisfaction.
Measured: FİVE MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Dec 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Halit Satici, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136000
- Sponsor's protocol ID
- STUDY SACRAL ERECTÖR
- Status last verified
- Apr 2024
- First submitted
- 8 Nov 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Circumcision Surgery: Comparison of the Effects of Erector Spina Plane Block and Ring Block on Postoperative Pain
- ClinicalTrials.gov ID
- NCT06136000
- Acronym / sponsor ID
- STUDY SACRAL ERECTÖR
- Conditions
- Pain, Pain, Postoperative
- Keywords
- erectör spinae plane block, ring block, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 18 Nov 2023 (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.
Although it is not known exactly when and where circumcision was first performed, it is claimed that it was first performed by the Egyptians, according to various beliefs and traditions. Circumcision is the surgical removal of the skin surrounding the glans penis in pediatric male patients and is the most commonly performed surgery in boys (4). Because the foreskin is sensitive and the pain threshold is low, patients experience severe pain in the postoperative period. Various analgesic methods have been developed to reduce this pain. Sacral surgery has started to be used in adult patients in recent years, but there is not enough information about its application in pediatric patients. Sacral erector spinae plane block is on the agenda. While sacral erectör spinae plane block was first applied in gender reassignment and pilonidal sinus surgery in adults, it was also applied to a small extent in hypospadias and anoplasty surgery in pediatric patients. In some studies, circumcision surgery involves the root and distal parts of the penis. It has been emphasized that ring blocks applied with anesthesia also have an analgesic effect. Our aim in this study was to compare the effect of S-ESPB and ring block on postoperative Face, Legs, Movement, Crying, Avocative Behavioral Scale pain scores in pediatric patients undergoing circumcision surgery and to compare the number of patients who required rescue analgesia, the time until the first rescue analgesia, possible complications, and parental satisfaction (a Likert scale will be used).
In this study, we found that sacral erectör spinae plane block is different from the ring block applied in routine practice in circumcision surgery. We think that postoperative analgesic effectiveness will be higher.
Our aim in this study was to compare the effect of sacral erectör spinae plane block and ring block on postoperative Face, Legs, Movement, Crying, Avocative Behavioral Scale pain score in pediatric patients undergoing circumcision surgery and to compare the number of patients who required rescue analgesia secondarily, the time until the first rescue analgesia, possible complications and parental satisfaction (Likert scale will be used).
Detailed description
Our primary hypothesis erectör spinae plane block will be effective in pediatric patients undergoing circumcision surgery. The effect on postoperative pain will be greater than the applied ring block and the Face, Legs, Movement, Crying, Avocative Behavioral Scale pain score will be lower.
Our secondary hypothesis is that the number of patients requiring rescue analgesia and the complications that may occur will be lower in sacral erectör spinae plane block to be applied in circumcision surgery compared to the ring block, and parental satisfaction and the time until the first rescue analgesia will be higher.
Material oath methods: Our study will be carried out within 6 months with 50 patients in the operating room of Konya City Hospital of the University of Health Sciences and the operating room of Harran University Faculty of Medicine Randomization This study was a multicenter prospective study. It was planned and will be carried out as a randomized study. Randomization will be carried out by the sealed envelope method. Patients will be divided into two groups: Group R (patients who underwent Ring block) and Group S (patients who underwent sacral erectör spinae plane block). Since it is a multicenter study, the anesthesia technique will be applied by two different physicians with at least five years of clinical experience and the postoperative results will be recorded by 2 different physicians. These physicians will evaluate patients completely independently and blindly. Written and verbal consent will be obtained from the patient's parents.
Anesthesia Technique and Analgesia Protocol:
Routine anesthesia monitoring and method will be applied to all patients. 22 gauge to patients Intravenous ( IV ) cannulation is provided and 15cc/kg/ h Isotonic fluid will be started. General anesthesia induction 1mg midazolam IV, 2 mg/kg propofol IV, and 1 mcg /kg remifentanil It will be done by giving IV. The patients will be fitted with a laryngeal mask airway (LMA), which we use in routine practice, and will require minimum anesthesia maintenance. alveolar Sevoflurane will be given with a concentration (MAC) value of 1. Before the surgical procedure begins, sacral erectör spinae plane block will be applied to the patients by the anesthesiologist or ring block by the pediatric surgeon. Then circumcision surgery will begin. The same surgical method will be applied to all patients.
At the end of the surgery, we routinely administer 15 mg/kg IV to all patients. Paracetamol will be given. Extubated patients will be transferred to the postanesthetic care unit (PACU) for observation. 0-1-2-4-6 from the time patients are admitted to the PACU until they are discharged from the hospital. Pain levels will be evaluated with the Face, Legs, Movement, Crying, Avocative Behavioral Scale pain scale. Patients with a Face, Legs, Movement, Crying, Avocative Behavioral Scale score of 4 and above will be given 10 mg/kg oral ibuprofen rescue analgesia. The number of patients requiring rescue analgesia, the time until the first rescue analgesia, complications that will develop, and parental satisfaction will be recorded.
sacral erectör spinae plane block with ultrasound guidance Group S will be placed on their side. Asepsis is fifth in the transverse plane under antisepsis standards. high-frequency [(10-15 millihertz ( mHz )] linear ultrasonography probe into the spinous process The ultrasonography probe will be shifted caudally to visualize the first and second median sacral crest. The USG probe is then placed on the second medial It will be placed 3-4 cm lateral to the sacral apex and the mid-sacral apex will be imaged. On the ultrasonography screen, from top to bottom, erector spinae muscle, multifidus muscle and sacral intermediate The crest will be displayed. 0.25% bupivacaine will be administered in a total volume of 0.5ml/kg (maximum 20 cc ) by applying negative aspiration with the in-plane technique with a 50 mm Stimuplex A needle. The process will be applied bilaterally.
Ring Block It is a block that is routinely performed in our clinic by a pediatric surgeon. The patient is under general anesthesia. Before the surgical procedure begins, the pediatric surgeon administers 0.5ml/kg (maximum 20cc) 0.25% bupivacaine to the base of the root of the penis with a 25-gauge needle at 3, 6, 9, and 12 o'clock. local It will be administered under anesthesia.
Primary evaluation criteria are the Face, Legs, Movement, Crying, Avocative Behavioral Scale of pain at rest and movement at 0, 1, 2, 4, and 6 hours after surgery (0-10, 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7- It will be evaluated with 10 = the most severe pain).
Secondary evaluation criteria are the number of patients needing rescue analgesia, the time until the first rescue analgesia, the complications that will develop, and parental satisfaction. The age, weight, height, and surgery duration of the patients in both groups were recorded. Likert evaluation test will be applied for parental satisfaction.
Sample Size:
for circumcision under general anesthesia. patients who will undergo surgery. In the sample size analysis, it was determined that there should be 19 patients for each group with a 95% power rate and an alpha margin of error of 0.05 for comparison of the two groups. The effect used for this calculation is 1.106, based on similar studies, actual power was calculated as 0.955. As a result of the analysis, drop Considering the out rate, it was planned to recruit 25 patients for each group (50 patients in total).
Statistical Analyzes To determine whether the data is normally distributed, the Shapiro Wilks test will be used. Descriptive statistical analyses will be used to evaluate demographic data and data obtained from tests and scales. A paired sample T-test will be used to compare data. Correlation analysis will be used to evaluate the relationship between data. Data will be expressed as mean ± standard deviation and percentage. P <0.05 will be considered statistically significant. In correlation analysis, confidence intervals and p-values will be evaluated according to whether they show a statistically significant or non-significant inverse interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SACRAL EREKTÖR SPİNAE PLANE BLOK | Active comparator | Other: Sacral erectör spinae plane block |
| RİNG BLOCK | Active comparator | Other: Ring Block |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients between the ages of 4-16
- patients with ASA I-II.
- Patients who will receive general anesthesia
Key exclusion criteria (5 listed)
- Parents and patients who do not want to give consent
- Patients with ASAIII and above
- Patients with a disordered bleeding profile
- Patients using anticoagulants
- Patients with infection in the area to be treated
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 |
|---|---|---|
| Sacral erectör spinae plane blockGroup S will be placed on their side. Asepsis is fifth in the transverse plane under antisepsis standards. high-frequency linear USG probe into the spinous process . The USG probe will be shifted caudally to visualize the first and second median sacral crest. The USG probe is then placed on the second medial It will be placed 3-4 cm lateral to the sacral apex and the mid-sacral apex will be imaged. On the USG screen, from top to bottom, erector spinae muscle, multifidus muscle and sacral intermediate The crest will be displayed. 0.25% bupivacaine will be administered in a total volume of 0.5ml/kg (maximum 20 cc ) by applying negative aspiration with the in-plane technique with a 50 mm Stimuplex A needle. | Other | SACRAL EREKTÖR SPİNAE PLANE BLOK |
| Ring BlockThe patient is under general anesthesia. Before the surgical procedure begins, the pediatric surgeon administers 0.5ml/kg (maximum 20cc) 0.25% bupivacaine to the base of the root of the penis with a 25-gauge needle at 3, 6, 9, and 12 o'clock. | Other | RİNG BLOCK |
Primary outcome
Face, Legs, Movement, Crying, Avocative Behavioral Scale
Time frame: FİVE MONTHS
Primary evaluation criteria are the Face, Legs, Movement, Crying, Avocative Behavioral Scaleof pain at rest and movement at 0, 1, 2, 4, and 6 hours after surgery (0-10, 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7- It will be evaluated with 10 = the most severe pain).
1 secondary outcome
Postoperative rescue analgesia
Time frame: FİVE MONTHS
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 16 Apr 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral erectör spinae plane block and Ring Block in people with Pain and Pain, Postoperative, run by Konya City 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 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 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?
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?
Face, Legs, Movement, Crying, Avocative Behavioral Scale (time frame: FİVE MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2024.