Hip FracturesNCT05397145
Iliopsoas Plane Block vs PENG Block for Hip Arthroplasty
A study testing Postoperative analgesia management in people with Hip Fractures and Hip Injuries, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Hip arthroplasty is one of the most common orthopedic procedures especially in elderly patients due to deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce opioid consumption and opioid-related side effects. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hip Fractures, Hip Injuries, Hip Arthropathy
- What is being tested?
- Postoperative analgesia management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2022to 30 Aug 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA classification I-III,
- Aged 20-80 years
- Who will be scheduled for hip arthroplasty under general anesthesia.
Who cannot join
- Patients who have a history of bleeding diathesis,
- Take anticoagulant therapy,
- History of chronic pain before surgery,
- Multiple trauma,
- Who cannot assess their pain (dementia),
- Who have been operated under spinal or epidural anesthesia,
- Who have an infection in the area and do not accept the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: Comparison of the Effect of Ultrasound-guided Iliopsoas Plane Block and PENG Block on Postoperative Analgesia Management in Patients Undergoing Hip Arthroplasty: A Randomized, Prospective Study
Hip arthroplasty is one of the most common orthopedic procedures especially in elderly patients due to deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce opioid consumption and opioid-related side effects. The hip joint consists of the femoral head and the acetabulum. Sensory innervation of the hip joint is provided by the femoral nerve, obturator nerve, articular branches of the sciatic nerve, and superior gluteal nerve. Because of the increasing use of ultrasound (US) in anesthesia practice, US-guided nerve blocks are widely used. Pericapsular nerve group block (PENG block) is a novel fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and the psoas tendon. The iliopsoas plane block (IPB) is a new block defined by Nielsen et al. It does not cause a motor block, but selectively blocks the sensory branches of the hip joint originating from the accessory obturator nerve and the femoral nerve. This prospective study compares the efficacy of PENG block and IPB for postoperative analgesia management in patients undergoing hip arthroplasty with a prosthesis.
Read the detailed description
Hip arthroplasty is one of the most common orthopedic procedures especially in elderly patients due to deformation of joints. Patients may complain of severe pain due to surgical trauma and the prosthesis. Opioid agents are commonly used for analgesia management. However, opioids have adverse effects such as nausea, vomiting, sedation, and respiratory depression. Regional anesthesia methods may be performed to reduce opioid consumption and opioid-related side effects. The hip joint consists of the femoral head and the acetabulum. Sensory innervation of the hip joint is provided by the femoral nerve, obturator nerve, articular branches of the sciatic nerve, and superior gluteal nerve. Skin innervation of the lateral femur is supplied by the lateral cutaneous femoral nerve. The upper anterior part of the thigh is innervated by the genitofemoral and ilioinguinal nerves. These nerves originate from the lumbar and sacral plexus. The innervation of the hip joint is complex, and the selection of the blocking technique is essential after these operations.
Pericapsular nerve group block (PENG block) is a novel fascial block defined by Arango et al. In this block, it is aimed blocking the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and the psoas tendon. By blocking these nerves, anterior hip analgesia is provided. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that total hip analgesia can be provided by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves when high volume is applied. Studies evaluating PENG block efficacy are limited in the literature.
The iliopsoas plane block (IPB) is a new block defined by Nielsen et al. It does not cause a motor block, but selectively blocks the sensory branches of the hip joint originating from the accessory obturator nerve and the femoral nerve. There is a study showing that it does not cause a motor block in healthy volunteers. Although there are case series in the literature reporting that it provides hip joint analgesia, there is no clinical study yet.
This prospective, randomized study aims to compare the efficacy of PENG block and IPB for postoperative analgesia management in patients undergoing hip arthroplasty with a prosthesis. Our primary aim is to compare postoperative opioid consumption, secondary aim is to evaluate pain scores (Numerical Rating Scale-NRS), quadriceps motor block (paresis or paralysis in knee extension), and side effects (allergic reaction, nausea, vomiting, etc.) associated with opioid use.
- Conditions
- Hip Fractures, Hip Injuries, Hip Arthropathy
- Being tested
- Postoperative analgesia management
- Keywords
- Hip arthroplasty, Postoperative pain management, PENG block, Iliopsoas plane block
- Medical subject headings
- Hip Fractures, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative analgesia managementOther
Intravenous 0.5 mg/kg tramodol and 400 mg ibuprofen will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered ibuprofen iv 400 mg 3x1. Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure. Patients in all groups will be attached to IV PCA containing 10 mcg/ml fentanyl, 10 mcg bolus without infusion dose, 10 min lock time protocol. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
| Study group | Role | What they receive |
|---|---|---|
| Group IPB = Iliopsoas plane block | Active comparator | While the patient is in the supine position, the probe will be placed in the transversal plane distal to the anterior superior iliac spine. Then, the probe will be rotated approximately 30° counterclockwise and slid along the inguinal ligament until the femoral head enters the edge of the acetabulum. The block needle will be passed through the sartorius and iliopsoas muscles and the iliopsoas plane between the iliopsoas muscle and the iliofemoral ligament will be reached. After the block site is confirmed with 5 ml of saline, 10 ml of local anesthetic solution containing 0.25% bupivacaine will be injected. Receives: Other: Postoperative analgesia management |
| Group PENG = PENG block | Active comparator | The probe will be placed on the anterior inferior iliac crest in the transverse plane. Then, the pubic ramus will be visualized by rotating 45 degrees. The femoral artery, iliopubic process, and psoas muscle will be visualized. The needle will be punctured with the in-plane method to reach between the pubic ramus and the psoas tendon. After the block site is confirmed with 5 ml of saline, 20 ml of local anesthetic solution containing 0.25% bupivacaine will be injected. Receives: Other: Postoperative analgesia management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
The fentanyl consumption on PCA device will be evaluated
Measured: Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16 and 24 hours.
Secondary outcomes (2)
Pain scores (Numerical Rating Scale-NRS)
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours
Quadriceps muscle strength
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start31 May 2022
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two models for this study. Iliopsoas plane block (IPB) group, and PENG block group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397145
- Sponsor's protocol ID
- Medipol Hospital 27
- Status last verified
- Sep 2024
- First submitted
- 25 May 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share IPD
Publications
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Lin DY, Morrison C, Brown B, Saies AA, Pawar R, Vermeulen M, Anderson SR, Lee TS, Doornberg J, Kroon HM, Jaarsma RL. Pericapsular nerve group (PENG) block provides improved short-term analgesia compared with the femoral nerve block in hip fracture surgery: a single-center double-blinded randomized comparative trial. Reg Anesth Pain Med. 2021 May;46(5):398-403. doi: 10.1136/rapm-2020-102315. Epub 2021 Feb 26.
PubMed 33637625Luo W, Liang J, Wu J, Luo Q, Wu H, Ou Y, Li Y, Ma W. Effects of pericapsular nerve group (PENG) block on postoperative recovery in elderly patients with hip fracture: study protocol for a randomised, parallel controlled, double-blind trial. BMJ Open. 2022 Mar 29;12(3):e051321. doi: 10.1136/bmjopen-2021-051321.
PubMed 35351697Yamak Altinpulluk E, Galluccio F, Salazar C, Espinoza K, Olea MS, Hochberg U, de Santiago J, Fajardo Perez M. Peng block in prosthetic hip replacement: A cadaveric radiological evaluation. J Clin Anesth. 2020 Oct;65:109888. doi: 10.1016/j.jclinane.2020.109888. Epub 2020 May 21. No abstract available.
PubMed 32447169Ciftci B, Ahiskalioglu A, Altintas HM, Tekin B, Sakul BU, Alici HA. A possible mechanism of motor blockade of high volume pericapsular nerve group (PENG) block: A cadaveric study. J Clin Anesth. 2021 Nov;74:110407. doi: 10.1016/j.jclinane.2021.110407. Epub 2021 Jun 24. No abstract available.
PubMed 34175637Wang CG, Yang Y, Yang MY, Wang XL, Ding YL. Analgesic effect of iliopsoas plane block for hip fracture. Perioper Med (Lond). 2022 Apr 14;11(1):15. doi: 10.1186/s13741-022-00254-3.
PubMed 35418144Nielsen ND, Madsen MN, Ostergaard HK, Bjorn S, Pedersen EM, Nielsen TD, Soballe K, Borglum J, Bendtsen TF. An iliopsoas plane block does not cause motor blockade-A blinded randomized volunteer trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):368-377. doi: 10.1111/aas.13498. Epub 2019 Nov 13.
PubMed 31650529
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Ultrasound-guided Iliopsoas Plane Block and PENG Block on Postoperative Analgesia Management in Patients Undergoing Hip Arthroplasty: A Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT05397145
- Acronym / sponsor ID
- Medipol Hospital 27
- Conditions
- Hip Fractures, Hip Injuries, Hip Arthropathy
- Keywords
- Hip arthroplasty, Postoperative pain management, PENG block, Iliopsoas plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 31 May 2022 (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.
Hip arthroplasty is one of the most common orthopedic procedures especially in elderly patients due to deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce opioid consumption and opioid-related side effects. The hip joint consists of the femoral head and the acetabulum. Sensory innervation of the hip joint is provided by the femoral nerve, obturator nerve, articular branches of the sciatic nerve, and superior gluteal nerve. Because of the increasing use of ultrasound (US) in anesthesia practice, US-guided nerve blocks are widely used. Pericapsular nerve group block (PENG block) is a novel fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and the psoas tendon. The iliopsoas plane block (IPB) is a new block defined by Nielsen et al. It does not cause a motor block, but selectively blocks the sensory branches of the hip joint originating from the accessory obturator nerve and the femoral nerve. This prospective study compares the efficacy of PENG block and IPB for postoperative analgesia management in patients undergoing hip arthroplasty with a prosthesis.
Detailed description
Hip arthroplasty is one of the most common orthopedic procedures especially in elderly patients due to deformation of joints. Patients may complain of severe pain due to surgical trauma and the prosthesis. Opioid agents are commonly used for analgesia management. However, opioids have adverse effects such as nausea, vomiting, sedation, and respiratory depression. Regional anesthesia methods may be performed to reduce opioid consumption and opioid-related side effects. The hip joint consists of the femoral head and the acetabulum. Sensory innervation of the hip joint is provided by the femoral nerve, obturator nerve, articular branches of the sciatic nerve, and superior gluteal nerve. Skin innervation of the lateral femur is supplied by the lateral cutaneous femoral nerve. The upper anterior part of the thigh is innervated by the genitofemoral and ilioinguinal nerves. These nerves originate from the lumbar and sacral plexus. The innervation of the hip joint is complex, and the selection of the blocking technique is essential after these operations.
Pericapsular nerve group block (PENG block) is a novel fascial block defined by Arango et al. In this block, it is aimed blocking the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and the psoas tendon. By blocking these nerves, anterior hip analgesia is provided. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that total hip analgesia can be provided by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves when high volume is applied. Studies evaluating PENG block efficacy are limited in the literature.
The iliopsoas plane block (IPB) is a new block defined by Nielsen et al. It does not cause a motor block, but selectively blocks the sensory branches of the hip joint originating from the accessory obturator nerve and the femoral nerve. There is a study showing that it does not cause a motor block in healthy volunteers. Although there are case series in the literature reporting that it provides hip joint analgesia, there is no clinical study yet.
This prospective, randomized study aims to compare the efficacy of PENG block and IPB for postoperative analgesia management in patients undergoing hip arthroplasty with a prosthesis. Our primary aim is to compare postoperative opioid consumption, secondary aim is to evaluate pain scores (Numerical Rating Scale-NRS), quadriceps motor block (paresis or paralysis in knee extension), and side effects (allergic reaction, nausea, vomiting, etc.) associated with opioid use.
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 models for this study. Iliopsoas plane block (IPB) group, and PENG block group.
| Arm | Type | Receives |
|---|---|---|
| Group IPB = Iliopsoas plane block | Active comparator | Other: Postoperative analgesia managementWhile the patient is in the supine position, the probe will be placed in the transversal plane distal to the anterior superior iliac spine. Then, the probe will be rotated approximately 30° counterclockwise and slid along the inguinal ligament until the femoral head enters the edge of the acetabulum. The block needle will be passed through the sartorius and iliopsoas muscles and the iliopsoas plane between the iliopsoas muscle and the iliofemoral ligament will be reached. After the block site is confirmed with 5 ml of saline, 10 ml of local anesthetic solution containing 0.25% bupivacaine will be injected. |
| Group PENG = PENG block | Active comparator | Other: Postoperative analgesia managementThe probe will be placed on the anterior inferior iliac crest in the transverse plane. Then, the pubic ramus will be visualized by rotating 45 degrees. The femoral artery, iliopubic process, and psoas muscle will be visualized. The needle will be punctured with the in-plane method to reach between the pubic ramus and the psoas tendon. After the block site is confirmed with 5 ml of saline, 20 ml of local anesthetic solution containing 0.25% bupivacaine will be injected. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ASA classification I-III,
- Aged 20-80 years
- Who will be scheduled for hip arthroplasty under general anesthesia.
Key exclusion criteria (7 listed)
- Patients who have a history of bleeding diathesis,
- Take anticoagulant therapy,
- History of chronic pain before surgery,
- Multiple trauma,
- Who cannot assess their pain (dementia),
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 |
|---|---|---|
| Postoperative analgesia managementIntravenous 0.5 mg/kg tramodol and 400 mg ibuprofen will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered ibuprofen iv 400 mg 3x1. Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure. Patients in all groups will be attached to IV PCA containing 10 mcg/ml fentanyl, 10 mcg bolus without infusion dose, 10 min lock time protocol. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. | Other | Group IPB = Iliopsoas plane block, Group PENG = PENG block |
Primary outcome
Opioid consumption
Time frame: Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16 and 24 hours.
The fentanyl consumption on PCA device will be evaluated
2 secondary outcomes
Pain scores (Numerical Rating Scale-NRS)
Time frame: Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours
Quadriceps muscle strength
Time frame: Postoperative 24 hours period
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 19 Sep 2024.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Background: PubMed 33637625Lin DY, Morrison C, Brown B, Saies AA, Pawar R, Vermeulen M, Anderson SR, Lee TS, Doornberg J, Kroon HM, Jaarsma RL. Pericapsular nerve group (PENG) block provides improved short-term analgesia compared with the femoral nerve block in hip fracture surgery: a single-center double-blinded randomized comparative trial. Reg Anesth Pain Med. 2021 May;46(5):398-403. doi: 10.1136/rapm-2020-102315. Epub 2021 Feb 26.
- Background: PubMed 35351697Luo W, Liang J, Wu J, Luo Q, Wu H, Ou Y, Li Y, Ma W. Effects of pericapsular nerve group (PENG) block on postoperative recovery in elderly patients with hip fracture: study protocol for a randomised, parallel controlled, double-blind trial. BMJ Open. 2022 Mar 29;12(3):e051321. doi: 10.1136/bmjopen-2021-051321.
- Background: PubMed 32447169Yamak Altinpulluk E, Galluccio F, Salazar C, Espinoza K, Olea MS, Hochberg U, de Santiago J, Fajardo Perez M. Peng block in prosthetic hip replacement: A cadaveric radiological evaluation. J Clin Anesth. 2020 Oct;65:109888. doi: 10.1016/j.jclinane.2020.109888. Epub 2020 May 21. No abstract available.
- Background: PubMed 34175637Ciftci B, Ahiskalioglu A, Altintas HM, Tekin B, Sakul BU, Alici HA. A possible mechanism of motor blockade of high volume pericapsular nerve group (PENG) block: A cadaveric study. J Clin Anesth. 2021 Nov;74:110407. doi: 10.1016/j.jclinane.2021.110407. Epub 2021 Jun 24. No abstract available.
- Background: PubMed 35418144Wang CG, Yang Y, Yang MY, Wang XL, Ding YL. Analgesic effect of iliopsoas plane block for hip fracture. Perioper Med (Lond). 2022 Apr 14;11(1):15. doi: 10.1186/s13741-022-00254-3.
- Background: PubMed 31650529Nielsen ND, Madsen MN, Ostergaard HK, Bjorn S, Pedersen EM, Nielsen TD, Soballe K, Borglum J, Bendtsen TF. An iliopsoas plane block does not cause motor blockade-A blinded randomized volunteer trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):368-377. doi: 10.1111/aas.13498. Epub 2019 Nov 13.
- Individual participant dataSharing planned: No. The investigators 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. 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 Postoperative analgesia management in people with Hip Fractures and Hip Injuries, run by Medipol 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 19 Sep 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?
Opioid consumption (time frame: Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16 and 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 NCT05397145, which also lists 7 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 19 Sep 2024.