Inguinal Hernia RepairNCT05073055
Spinal Anesthesia Versus Erector Spina Plane Block
A study testing İnguinal Hernia Repair in people with Inguinal Hernia Repair and Postoperative Pain, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of our study was to use spinal anesthesia for unilateral inguinal hernia surgery and lumbar erector spina block supported by local infiltration anesthesia in terms of operation time, intraoperative hemodynamic data, motor block onset time, block termination time, analgesic need, discharge time, patient… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Inguinal Hernia Repair, Postoperative Pain, Peripheral Nerve Blocks
- What is being tested?
- İnguinal Hernia Repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 25 Dec 2022
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing inguinal hernia repair.
- Unilateral inguinal hernia.
- Patients with ASA II-III preoperative anesthesia score.
Who cannot join
- Patients with liver disease,
- allergy to anesthetic agents
- local infection,
- recurrence,
- strangulated hernia,
- patients with a history of allergy to local anesthetics,
- patients with a history of anesthesia up to two weeks ago
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Spinal Anesthesia and Erector Spina Plane Block in Unilateral Inguinal Hernias: A Randomized Controlled Study
The primary aim of our study was to use spinal anesthesia for unilateral inguinal hernia surgery and lumbar erector spina block supported by local infiltration anesthesia in terms of operation time, intraoperative hemodynamic data, motor block onset time, block termination time, analgesic need, discharge time, patient satisfaction, surgeon satisfaction. is to compare. Its second purpose is to observe nausea, vomiting, urinary retention, headache, chills, bleeding, wound infection.
Read the detailed description
Seventy cases of the American Society of Anesthesia physical status (ASA) I-III class between the ages of 18-75 who were hospitalized in the general surgery clinic with the diagnosis of unilateral inguinal hernia will be enrolled in this study prospectively and randomly. The entire work will be conducted in accordance with the principles of the Declaration of Helsinki. The patients will be determined one day in advance with the single-blind method and the closed envelope method, and all patients will be informed about the study plan in detail, and informed patient consent will be obtained.
Patients with liver disease, allergy to anesthetic agents, local infection, recurrence, strangulated hernia, patients with a history of allergy to local anesthetics, and patients with a history of anesthesia up to two weeks ago will be excluded from the study. The general surgeon who performs the inguinal hernia repair surgery will not take part in the postoperative follow-up of the patients. Patients with a diagnosis of inguinal hernia who are operated on in our hospital are administered 0.1 mg.kg-midazolam 30 minutes before the block application. Electrocardiogram (ECG), heart rate (HR), peripheral oxygen saturation (SpO2) are monitored in the pre-anesthesia preparation room, and nasal hydration application with 2 l / min O2 and 5 ml kg hr, 0.9% NaCl is started. These patients will be randomly divided into two groups. Patients who underwent spinal anesthesia will be named as Group 1, and patients who underwent Erectile Spina Block and Tumescent anesthesia as Group 2.
Group 1 (SE) (n = 35): patients undergoing spinal anesthesia of patients in our hospital to do unilateral inguinal hernia operation, is taken to a seated position on the operating table and a 25 gauge spinal needle under sterile conditions (dominant, Turkey) subarachnoid space entered% in 30 seconds 0, 5 units of levobupivacaine 3 mL is injected. The intervention is started after the patients are placed in the supine position immediately after the spinal block and the level of the sensory block is confirmed by the pin prick test to be at the T10 dermatome. Block application and the times when the sensory block reaches the T10 level are recorded. Surgery is allowed in patients who develop sensory block at the T10 level. During our study, no changes will be made to the procedure described above, which is standardized during our study, only patient data will be recorded observationally. Patients who do not have sufficient sensory block to start the procedure despite waiting 10 minutes will be registered and excluded from the study and additional anesthesia will be applied.
Group 2 (Errector spina block + TA) (n = 35): To be used for each patient before the operation to apply tumescent anesthesia-assisted erectile spina block to patients undergoing unilateral inguinal hernia operation in our hospital with erectile spina block + infiltration anesthesia method. A total of 30 ml of mixture is prepared including lidocaine hydrochloride 10mg / ml, adrenaline tartarate (1: 1000) 5 μg / mL, 13 ml in total, 0.5% bupivacaine hydrochloride 13 ml, Sterile Serum 8.4% Sodium Bicarbonate 4 ml. After hemodynamic stability, the patient is placed in the lateral position and infiltration anesthesia with 2% lidocaine is applied. Following aseptic preparation of the skin and probe, a high-frequency linear USG transducer is moved 2.5 cm laterally in the parasagittal plane to visualize the transverse projection of the first lumbar (L1) vertebra. The needle, with real-time imaging of the spreading injected material, TP of L1 and at this level, just below the erector spina muscle, 5 cm, 21G peripheral nerve block needle (Pajuk®, stimuplex HNS12 Germany, Germany) is preferred. During the application, the needle is inserted perpendicular to the skin. Unilateral block is applied at T12 and L1 levels, with 10 ml in each segment. After the needle is withdrawn, pressure is applied to the injection area for 2 minutes and then, the patient is taken to the operation room, the prepared local anesthetic mixture is applied to the patient using the step-by-step technique, 5 ml under the skin and the subcutaneous area around the incision, and the other 5 ml under the fascia, the funiculus (spermatic cord). Tumescent anesthesia is applied around the area and the tissues at the base of the hernia sac. Surgery is permitted in patients who develop sensory block between T10-L1 dermatomes. In our study, patients whose sensory block is controlled by pin-prick test, and patients whose local anesthesia does not create sufficient sensory block to start the skin incision will be excluded from the study and additional anesthesia methods will be applied. The time during which the sensory blocks of the patients disappear will be recorded.
During surgery, the sedation level of the patients will be monitored with the Ramsey sedation score (1: agitated, anxiosis, 2: cooperative, 3: response to verbal commands, 4: vivid response to glabella hit or loud stimulus, 5: lazy response to glabella beat or loud stimulus, 6 : no answer).
- Being tested
- İnguinal Hernia Repair
- Keywords
- nerve block, inguinal hernia, anesthesia, spinal
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İnguinal Hernia RepairProcedure or surgery
Also called Erectör spinae block, Spinal Anesthesia
After hemodynamic stability, the patient was placed in the lateral position and infiltration anesthesia with 2% lidocaine was applied. Following aseptic preparation of the skin and probe, a medium-frequency curvey USG transducer was first placed in the midline to visualize the transverse projection of the first lumbar (L1) vertebra, then moved 2.5 cm laterally in the parasagittal plane, after imaging the transverse process, in-plane spreading was injected. Hydrodissection was achieved on the TP of L1 by using a 5 cm, 21G peripheral nerve block needle just below the erector spina muscle with real-time imaging of the substance. Afterwards, a unilateral injection of 15 ml at T12 and L1 levels was applied to each segment with the needle directed at two different angles from the same insertion point.
| Study group | Role | What they receive |
|---|---|---|
| Group SA | Active comparator | Group 1 (SE) (n = 35): patients undergoing spinal anesthesia of patients in our hospital to do unilateral inguinal hernia operation. Block application and the times when the sensory block reaches the T10 level are recorded. Surgery is allowed in patients who develop sensory block at the T10 level. During our study, no changes will be made to the procedure described above, which is standardized during our study, only patient data will be recorded observationally. Patients who do not have sufficient sensory block to start the procedure despite waiting 10 minutes will be registered and excluded from the study and additional anesthesia will be applied. Receives: Procedure: İnguinal Hernia Repair |
| Group ESP+TA | Active comparator | Group 2 (Errector spina block + TA) (n = 35): 2% lidocaine hydrochloride (10 mg / ml) 15 ml, 0.5% bupivacaine hydrochloride (20 mg / ml) 15 ml, serum 8.4% Sodium Bicarbonate 5 ml to be used for each patient before the operation in order to apply the erectile spina block block with tumescent anesthesia. Adding adrenaline tartrate (5 μg / mL) to 5 ml with saline, a total of 40 ml of mixture was prepared. Hydrodissection was achieved using a 5 cm, 21G peripheral nerve block needle just below the erector spina muscle on the Transverse Process of L1. Afterwards, a unilateral injection of 15 ml at T12 and L1 levels was applied to each segment with the needle directed at two different angles from the same insertion point. Receives: Procedure: İnguinal Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative pain score
The pain level felt by the patients during the operation will be measured using a visual analog scale. The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image.0 means being painless and 10 means the most severe pain.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Jan 2021
- Primary completion28 Sep 2021
- Study completion25 Dec 2022
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 Inguinal Hernia RepairStudies 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
- Spinal anesthesia was determined as the standard method. Erectile spina block was determined as a research group. There were equal numbers of patients in both groups. The patients to be assigned to the groups were determined by the closed envelope drawing method.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kaçmaz, Nigde Omer Halisdemir University
- Investigators
- Mustafa KAÇMAZ, Md, Study director, Ömer Halisdemir Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073055
- Sponsor's protocol ID
- 2020/38
- Status last verified
- Dec 2022
- First submitted
- 22 Mar 2021
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Group information, intraoperative and postoperative pain scores, amount of analgesic use, and length of stay in the hospital will be shared.
Publications
Aksu C, Gurkan Y. Opioid sparing effect of Erector Spinae Plane block for pediatric bilateral inguinal hernia surgeries. J Clin Anesth. 2018 Nov;50:62-63. doi: 10.1016/j.jclinane.2018.06.048. Epub 2018 Jul 1. No abstract available.
PubMed 29980003Schwartzmann A, Peng P, Maciel MA, Forero M. Mechanism of the erector spinae plane block: insights from a magnetic resonance imaging study. Can J Anaesth. 2018 Oct;65(10):1165-1166. doi: 10.1007/s12630-018-1187-y. Epub 2018 Aug 3. No abstract available.
PubMed 30076575Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.
PubMed 29670771
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spinal Anesthesia and Erector Spina Plane Block in Unilateral Inguinal Hernias: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05073055
- Acronym / sponsor ID
- 2020/38
- Keywords
- nerve block, inguinal hernia, anesthesia, spinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 11 Oct 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.
The primary aim of our study was to use spinal anesthesia for unilateral inguinal hernia surgery and lumbar erector spina block supported by local infiltration anesthesia in terms of operation time, intraoperative hemodynamic data, motor block onset time, block termination time, analgesic need, discharge time, patient satisfaction, surgeon satisfaction. is to compare. Its second purpose is to observe nausea, vomiting, urinary retention, headache, chills, bleeding, wound infection.
Detailed description
Seventy cases of the American Society of Anesthesia physical status (ASA) I-III class between the ages of 18-75 who were hospitalized in the general surgery clinic with the diagnosis of unilateral inguinal hernia will be enrolled in this study prospectively and randomly. The entire work will be conducted in accordance with the principles of the Declaration of Helsinki. The patients will be determined one day in advance with the single-blind method and the closed envelope method, and all patients will be informed about the study plan in detail, and informed patient consent will be obtained.
Patients with liver disease, allergy to anesthetic agents, local infection, recurrence, strangulated hernia, patients with a history of allergy to local anesthetics, and patients with a history of anesthesia up to two weeks ago will be excluded from the study. The general surgeon who performs the inguinal hernia repair surgery will not take part in the postoperative follow-up of the patients. Patients with a diagnosis of inguinal hernia who are operated on in our hospital are administered 0.1 mg.kg-midazolam 30 minutes before the block application. Electrocardiogram (ECG), heart rate (HR), peripheral oxygen saturation (SpO2) are monitored in the pre-anesthesia preparation room, and nasal hydration application with 2 l / min O2 and 5 ml kg hr, 0.9% NaCl is started. These patients will be randomly divided into two groups. Patients who underwent spinal anesthesia will be named as Group 1, and patients who underwent Erectile Spina Block and Tumescent anesthesia as Group 2.
Group 1 (SE) (n = 35): patients undergoing spinal anesthesia of patients in our hospital to do unilateral inguinal hernia operation, is taken to a seated position on the operating table and a 25 gauge spinal needle under sterile conditions (dominant, Turkey) subarachnoid space entered% in 30 seconds 0, 5 units of levobupivacaine 3 mL is injected. The intervention is started after the patients are placed in the supine position immediately after the spinal block and the level of the sensory block is confirmed by the pin prick test to be at the T10 dermatome. Block application and the times when the sensory block reaches the T10 level are recorded. Surgery is allowed in patients who develop sensory block at the T10 level. During our study, no changes will be made to the procedure described above, which is standardized during our study, only patient data will be recorded observationally. Patients who do not have sufficient sensory block to start the procedure despite waiting 10 minutes will be registered and excluded from the study and additional anesthesia will be applied.
Group 2 (Errector spina block + TA) (n = 35): To be used for each patient before the operation to apply tumescent anesthesia-assisted erectile spina block to patients undergoing unilateral inguinal hernia operation in our hospital with erectile spina block + infiltration anesthesia method. A total of 30 ml of mixture is prepared including lidocaine hydrochloride 10mg / ml, adrenaline tartarate (1: 1000) 5 μg / mL, 13 ml in total, 0.5% bupivacaine hydrochloride 13 ml, Sterile Serum 8.4% Sodium Bicarbonate 4 ml. After hemodynamic stability, the patient is placed in the lateral position and infiltration anesthesia with 2% lidocaine is applied. Following aseptic preparation of the skin and probe, a high-frequency linear USG transducer is moved 2.5 cm laterally in the parasagittal plane to visualize the transverse projection of the first lumbar (L1) vertebra. The needle, with real-time imaging of the spreading injected material, TP of L1 and at this level, just below the erector spina muscle, 5 cm, 21G peripheral nerve block needle (Pajuk®, stimuplex HNS12 Germany, Germany) is preferred. During the application, the needle is inserted perpendicular to the skin. Unilateral block is applied at T12 and L1 levels, with 10 ml in each segment. After the needle is withdrawn, pressure is applied to the injection area for 2 minutes and then, the patient is taken to the operation room, the prepared local anesthetic mixture is applied to the patient using the step-by-step technique, 5 ml under the skin and the subcutaneous area around the incision, and the other 5 ml under the fascia, the funiculus (spermatic cord). Tumescent anesthesia is applied around the area and the tissues at the base of the hernia sac. Surgery is permitted in patients who develop sensory block between T10-L1 dermatomes. In our study, patients whose sensory block is controlled by pin-prick test, and patients whose local anesthesia does not create sufficient sensory block to start the skin incision will be excluded from the study and additional anesthesia methods will be applied. The time during which the sensory blocks of the patients disappear will be recorded.
During surgery, the sedation level of the patients will be monitored with the Ramsey sedation score (1: agitated, anxiosis, 2: cooperative, 3: response to verbal commands, 4: vivid response to glabella hit or loud stimulus, 5: lazy response to glabella beat or loud stimulus, 6 : no answer).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Spinal anesthesia was determined as the standard method. Erectile spina block was determined as a research group. There were equal numbers of patients in both groups. The patients to be assigned to the groups were determined by the closed envelope drawing method.
| Arm | Type | Receives |
|---|---|---|
| Group SA | Active comparator | Procedure: İnguinal Hernia RepairGroup 1 (SE) (n = 35): patients undergoing spinal anesthesia of patients in our hospital to do unilateral inguinal hernia operation. Block application and the times when the sensory block reaches the T10 level are recorded. Surgery is allowed in patients who develop sensory block at the T10 level. During our study, no changes will be made to the procedure described above, which is standardized during our study, only patient data will be recorded observationally. Patients who do not have sufficient sensory block to start the procedure despite waiting 10 minutes will be registered and excluded from the study and additional anesthesia will be applied. |
| Group ESP+TA | Active comparator | Procedure: İnguinal Hernia RepairGroup 2 (Errector spina block + TA) (n = 35): 2% lidocaine hydrochloride (10 mg / ml) 15 ml, 0.5% bupivacaine hydrochloride (20 mg / ml) 15 ml, serum 8.4% Sodium Bicarbonate 5 ml to be used for each patient before the operation in order to apply the erectile spina block block with tumescent anesthesia. Adding adrenaline tartrate (5 μg / mL) to 5 ml with saline, a total of 40 ml of mixture was prepared. Hydrodissection was achieved using a 5 cm, 21G peripheral nerve block needle just below the erector spina muscle on the Transverse Process of L1. Afterwards, a unilateral injection of 15 ml at T12 and L1 levels was applied to each segment with the needle directed at two different angles from the same insertion point. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing inguinal hernia repair.
- Unilateral inguinal hernia.
- Patients with ASA II-III preoperative anesthesia score.
Key exclusion criteria (7 listed)
- Patients with liver disease,
- allergy to anesthetic agents
- local infection,
- recurrence,
- strangulated hernia,
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 |
|---|---|---|
| İnguinal Hernia RepairAlso: Erectör spinae block, Spinal AnesthesiaAfter hemodynamic stability, the patient was placed in the lateral position and infiltration anesthesia with 2% lidocaine was applied. Following aseptic preparation of the skin and probe, a medium-frequency curvey USG transducer was first placed in the midline to visualize the transverse projection of the first lumbar (L1) vertebra, then moved 2.5 cm laterally in the parasagittal plane, after imaging the transverse process, in-plane spreading was injected. Hydrodissection was achieved on the TP of L1 by using a 5 cm, 21G peripheral nerve block needle just below the erector spina muscle with real-time imaging of the substance. Afterwards, a unilateral injection of 15 ml at T12 and L1 levels was applied to each segment with the needle directed at two different angles from the same insertion point. | Procedure or surgery | Group ESP+TA, Group SA |
Primary outcome
Intraoperative pain score
Time frame: 5 month
The pain level felt by the patients during the operation will be measured using a visual analog scale. The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image.0 means being painless and 10 means the most severe pain.
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 28 Dec 2022.
- Results publication: PubMed 29980003Aksu C, Gurkan Y. Opioid sparing effect of Erector Spinae Plane block for pediatric bilateral inguinal hernia surgeries. J Clin Anesth. 2018 Nov;50:62-63. doi: 10.1016/j.jclinane.2018.06.048. Epub 2018 Jul 1. No abstract available.
- Results publication: PubMed 30076575Schwartzmann A, Peng P, Maciel MA, Forero M. Mechanism of the erector spinae plane block: insights from a magnetic resonance imaging study. Can J Anaesth. 2018 Oct;65(10):1165-1166. doi: 10.1007/s12630-018-1187-y. Epub 2018 Aug 3. No abstract available.
- Results publication: PubMed 29670771Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.
- Individual participant dataSharing planned: No. Group information, intraoperative and postoperative pain scores, amount of analgesic use, and length of stay in the hospital will be shared.
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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.
Mustafa KAÇMAZ, Md study director
Ömer Halisdemir Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing İnguinal Hernia Repair in people with Inguinal Hernia Repair and Postoperative Pain, run by Nigde Omer Halisdemir University 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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. 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?
Intraoperative pain score (time frame: 5 month). 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 NCT05073055, 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 28 Dec 2022.