POSTOPERATIVE ANALGESIANCT06040879
PENG Block and Lateral Femoral Cutaneous Nerve Block For Hip Replacement Surgery
A study testing PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCK in people with POSTOPERATIVE ANALGESIA, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
Background: this study aimed to describe the pain relief outcomes after hip replacement surgery by continuous Pericapsular Nerve Group Block (PENG Block) in combination with lateral femoral cutaneous nerve (LFCN) block under the guidance of ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- POSTOPERATIVE ANALGESIA
- What is being tested?
- PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCK
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2021to 3 Sep 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients had hip replacement surgery.
Who cannot join
- infection of the anesthetized area.
- coagulation disorders
- organs dysfunction
- allergy to anesthetics
- did not cooperate with physicians
- history of opioid dependence
- inability to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia Outcomes Of Pericapsular Nerve Group Block (PENG Block) Combined With Lateral Femoral Cutaneous Nerve Block After Hip Replacement Surgery: A Randomized Controlled Study
Background: this study aimed to describe the pain relief outcomes after hip replacement surgery by continuous Pericapsular Nerve Group Block (PENG Block) in combination with lateral femoral cutaneous nerve (LFCN) block under the guidance of ultrasound.
Methods: patients who had hip surgery at E University hospital, Hanoi, Vietnam from August 2021 to August 2022 belonged to two groups: group of patients with pain relief with PENG block in combination with LFCN block (PENG BLOCK group) and group of patients with patient-controlled intravenous analgesia (PCA group). Outcomes regarding clinical and pain score from initiation of insertion or PCA insertion (H0) to after 72 hours (H72) were recorded.
Read the detailed description
First, patients were explained about the study and asked to sign written informed consent if they agreed to participate in the study. Next, the patient was instructed to use the visual analogue scale (VAS) for pain score, as well as how to press the button to request pain relief. Then, a monitor was installed and operated to assess the clinical parameters (electrocardiogram, blood pressure, SpO2, arterial blood pressure, temperature). The patient was oxygenated 3-5 liters/minute and performed a peripheral intravenous line, with an 18G catheter, infused with 0.9% NaCl solution. Spinal anesthesia was administered with ropivacaine 0.5% and fentanyl.
During and after the surgery, a group of patients received intravenous morphine analgesia via PCA (concentration 1mg/ml, bolus dose of 1mg, lock time 10 minutes, maximum dose 10mg/4 hours). The remaining group of patients receive pain relief by PENG block and LFCN block. In this group, the ultrasound probe was placed horizontally from the anterior superior iliac spine, and was moved along the femoral arc defining the pubic spine. Then, the transducer was rotated 45 degrees, moved parallel to the femoral arch identifying the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE) and inferior lumbosacral head. The ultrasound probe was moved lightly until the upper end of the femoral head was identified. Next, a 120 mm Tuohy 18G anesthetic needle was used under ultrasound guidance, which was moved lateral to medial in the plane between the ultrasound transducer and the superior tip of the femoral head. Then, 10 mL of ropivacaine 0.25% was injected through the anesthetic needle tip.
Data were collected at different times including: before surgery, before anesthesia, during surgery and after surgery. The information was recorded in the medical record.
Preoperative data: the collected information included the general characteristics of the study patients including age, gender, weight, height, history of smoking/motion sickness, diagnosis, health classification according to ASA, liver and kidney function tests. With pre-anesthesia data, information was collected including pulse, blood pressure, respiratory rate, SpO2.
Intraoperative data: the information collected includes information about anesthesia and surgical procedure.
Post-operative data: the collected information includes blood test results (urea, creatinine, liver enzymes), pain score (Visual analogue scale - VAS - scale from 0 to 10, the higher the score, the higher the pain level. more), analgesic drugs consumption status, respiratory and circulatory changes, adverse events, and analgesic satisfaction. Time was recorded from initiation of catheterization or PCA insertion (H0) to after 72 hours (H72).
- Conditions
- POSTOPERATIVE ANALGESIA
- Being tested
- PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCK
- Keywords
- Pericapsular Nerve Group Block, lateral femoral cutaneous nerve, multimodal analgesia, ultrasound-guided analgesia, patient-controlled analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCKProcedure or surgery
During and after the surgery, a group of patients received intravenous morphine analgesia via PCA (concentration 1mg/ml, bolus dose of 1mg, lock time 10 minutes, maximum dose 10mg/4 hours). The remaining group of patients receive pain relief by PENG block and LFCN block. In this group, the ultrasound probe was placed horizontally from the anterior superior iliac spine, and was moved along the femoral arc defining the pubic spine. Then, the transducer was rotated 45 degrees, moved parallel to the femoral arch identifying the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE) and inferior lumbosacral head. The ultrasound probe was moved lightly until the upper end of the femoral head was identified. Next, a 120 mm Tuohy 18G anesthetic needle was used under ultrasound guidance, which was moved lateral to medial in the plane between the ultrasound transducer and the superior tip of the femoral head. Then, 10 mL of ropivacaine 0.25% was injected through the anesthetic needle tip
| Study group | Role | What they receive |
|---|---|---|
| PENG BLOCK | Experimental | receiving pain relief through PENG and LFCN block Receives: Procedure: PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCK |
| PCA | Active comparator | receiving morphine PCA analgesia Receives: Procedure: PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCK |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score at rest and on movement
the average VAS score (Visual Analogue Scale) at rest and on movement of both groups. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark.
Measured: Time was recorded from initiation of catheterization or PCA insertion (H0) to after 72 hours (H72)
Side effects
Rate of vomitting/nausea, itchy, urinary retention, respiratory failure postoperative of both groups.
Measured: Time was recorded from initiation of catheterization or PCA insertion (H0) to after 72 hours (H72)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Aug 2021
- Primary completion31 Aug 2022
- Study completion3 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for POSTOPERATIVE ANALGESIAStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PCA group and PENG BLOCK group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tu Nguyen, Professor, Study director, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040879
- Sponsor's protocol ID
- HMU09.2023
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We agree that all results and conclusion of this research will be used fully for other researchers
Publications
Ferguson RJ, Palmer AJ, Taylor A, Porter ML, Malchau H, Glyn-Jones S. Hip replacement. Lancet. 2018 Nov 3;392(10158):1662-1671. doi: 10.1016/S0140-6736(18)31777-X.
PubMed 30496081Ferrata P, Carta S, Fortina M, Scipio D, Riva A, Di Giacinto S. Painful hip arthroplasty: definition. Clin Cases Miner Bone Metab. 2011 May;8(2):19-22.
PubMed 22461810YaDeau JT, Tedore T, Goytizolo EA, Kim DH, Green DS, Westrick A, Fan R, Rade MC, Ranawat AS, Coleman SH, Kelly BT. Lumbar plexus blockade reduces pain after hip arthroscopy: a prospective randomized controlled trial. Anesth Analg. 2012 Oct;115(4):968-72. doi: 10.1213/ANE.0b013e318265bacd. Epub 2012 Jul 19.
PubMed 22822195Duarte LT, Beraldo PS, Saraiva RA. [Effects of epidural analgesia and continuous lumbar plexus block on functional rehabilitation after total hip arthroplasty]. Rev Bras Anestesiol. 2009 Sep-Oct;59(5):531-44. doi: 10.1016/s0034-7094(09)70078-9. Portuguese.
PubMed 19784509Singelyn FJ, Ferrant T, Malisse MF, Joris D. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):452-7. doi: 10.1016/j.rapm.2005.05.008.
PubMed 16135349Lin 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 33637625Shafiq F, Hamid M, Samad K. Complications and interventions associated with epidural analgesia for postoperative pain relief in a tertiary care hospital. Middle East J Anaesthesiol. 2010 Oct;20(6):827-32.
PubMed 21526668Rasouli MR, Viscusi ER. Adductor Canal Block for Knee Surgeries: An Emerging Analgesic Technique. Arch Bone Jt Surg. 2017 May;5(3):131-132. No abstract available.
PubMed 28656158Kamel I, Ahmed MF, Sethi A. Regional anesthesia for orthopedic procedures: What orthopedic surgeons need to know. World J Orthop. 2022 Jan 18;13(1):11-35. doi: 10.5312/wjo.v13.i1.11. eCollection 2022 Jan 18.
PubMed 35096534
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia Outcomes Of Pericapsular Nerve Group Block (PENG Block) Combined With Lateral Femoral Cutaneous Nerve Block After Hip Replacement Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06040879
- Acronym / sponsor ID
- HMU09.2023
- Conditions
- POSTOPERATIVE ANALGESIA
- Keywords
- Pericapsular Nerve Group Block, lateral femoral cutaneous nerve, multimodal analgesia, ultrasound-guided analgesia, patient-controlled analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 3 Sep 2022 (actual)
- First posted
- 18 Sep 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.
Background: this study aimed to describe the pain relief outcomes after hip replacement surgery by continuous Pericapsular Nerve Group Block (PENG Block) in combination with lateral femoral cutaneous nerve (LFCN) block under the guidance of ultrasound.
Methods: patients who had hip surgery at E University hospital, Hanoi, Vietnam from August 2021 to August 2022 belonged to two groups: group of patients with pain relief with PENG block in combination with LFCN block (PENG BLOCK group) and group of patients with patient-controlled intravenous analgesia (PCA group). Outcomes regarding clinical and pain score from initiation of insertion or PCA insertion (H0) to after 72 hours (H72) were recorded.
Detailed description
First, patients were explained about the study and asked to sign written informed consent if they agreed to participate in the study. Next, the patient was instructed to use the visual analogue scale (VAS) for pain score, as well as how to press the button to request pain relief. Then, a monitor was installed and operated to assess the clinical parameters (electrocardiogram, blood pressure, SpO2, arterial blood pressure, temperature). The patient was oxygenated 3-5 liters/minute and performed a peripheral intravenous line, with an 18G catheter, infused with 0.9% NaCl solution. Spinal anesthesia was administered with ropivacaine 0.5% and fentanyl.
During and after the surgery, a group of patients received intravenous morphine analgesia via PCA (concentration 1mg/ml, bolus dose of 1mg, lock time 10 minutes, maximum dose 10mg/4 hours). The remaining group of patients receive pain relief by PENG block and LFCN block. In this group, the ultrasound probe was placed horizontally from the anterior superior iliac spine, and was moved along the femoral arc defining the pubic spine. Then, the transducer was rotated 45 degrees, moved parallel to the femoral arch identifying the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE) and inferior lumbosacral head. The ultrasound probe was moved lightly until the upper end of the femoral head was identified. Next, a 120 mm Tuohy 18G anesthetic needle was used under ultrasound guidance, which was moved lateral to medial in the plane between the ultrasound transducer and the superior tip of the femoral head. Then, 10 mL of ropivacaine 0.25% was injected through the anesthetic needle tip.
Data were collected at different times including: before surgery, before anesthesia, during surgery and after surgery. The information was recorded in the medical record.
Preoperative data: the collected information included the general characteristics of the study patients including age, gender, weight, height, history of smoking/motion sickness, diagnosis, health classification according to ASA, liver and kidney function tests. With pre-anesthesia data, information was collected including pulse, blood pressure, respiratory rate, SpO2.
Intraoperative data: the information collected includes information about anesthesia and surgical procedure.
Post-operative data: the collected information includes blood test results (urea, creatinine, liver enzymes), pain score (Visual analogue scale - VAS - scale from 0 to 10, the higher the score, the higher the pain level. more), analgesic drugs consumption status, respiratory and circulatory changes, adverse events, and analgesic satisfaction. Time was recorded from initiation of catheterization or PCA insertion (H0) to after 72 hours (H72).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- PCA group and PENG BLOCK group
| Arm | Type | Receives |
|---|---|---|
| PENG BLOCK | Experimental | Procedure: PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCKreceiving pain relief through PENG and LFCN block |
| PCA | Active comparator | Procedure: PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCKreceiving morphine PCA analgesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients had hip replacement surgery.
Key exclusion criteria (7 listed)
- infection of the anesthetized area.
- coagulation disorders
- organs dysfunction
- allergy to anesthetics
- did not cooperate with physicians
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 |
|---|---|---|
| PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCKDuring and after the surgery, a group of patients received intravenous morphine analgesia via PCA (concentration 1mg/ml, bolus dose of 1mg, lock time 10 minutes, maximum dose 10mg/4 hours). The remaining group of patients receive pain relief by PENG block and LFCN block. In this group, the ultrasound probe was placed horizontally from the anterior superior iliac spine, and was moved along the femoral arc defining the pubic spine. Then, the transducer was rotated 45 degrees, moved parallel to the femoral arch identifying the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE) and inferior lumbosacral head. The ultrasound probe was moved lightly until the upper end of the femoral head was identified. Next, a 120 mm Tuohy 18G anesthetic needle was used under ultrasound guidance, which was moved lateral to medial in the plane between the ultrasound transducer and the superior tip of the femoral head. Then, 10 mL of ropivacaine 0.25% was injected through the anesthetic needle tip | Procedure or surgery | PCA, PENG BLOCK |
Primary outcome
VAS score at rest and on movement
Time frame: Time was recorded from initiation of catheterization or PCA insertion (H0) to after 72 hours (H72)
the average VAS score (Visual Analogue Scale) at rest and on movement of both groups. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark.
Side effects
Time frame: Time was recorded from initiation of catheterization or PCA insertion (H0) to after 72 hours (H72)
Rate of vomitting/nausea, itchy, urinary retention, respiratory failure postoperative of both groups.
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 18 Sep 2023.
- Results publication: PubMed 30496081Ferguson RJ, Palmer AJ, Taylor A, Porter ML, Malchau H, Glyn-Jones S. Hip replacement. Lancet. 2018 Nov 3;392(10158):1662-1671. doi: 10.1016/S0140-6736(18)31777-X.
- Results publication: PubMed 22461810Ferrata P, Carta S, Fortina M, Scipio D, Riva A, Di Giacinto S. Painful hip arthroplasty: definition. Clin Cases Miner Bone Metab. 2011 May;8(2):19-22.
- Results publication: PubMed 22822195YaDeau JT, Tedore T, Goytizolo EA, Kim DH, Green DS, Westrick A, Fan R, Rade MC, Ranawat AS, Coleman SH, Kelly BT. Lumbar plexus blockade reduces pain after hip arthroscopy: a prospective randomized controlled trial. Anesth Analg. 2012 Oct;115(4):968-72. doi: 10.1213/ANE.0b013e318265bacd. Epub 2012 Jul 19.
- Results publication: PubMed 19784509Duarte LT, Beraldo PS, Saraiva RA. [Effects of epidural analgesia and continuous lumbar plexus block on functional rehabilitation after total hip arthroplasty]. Rev Bras Anestesiol. 2009 Sep-Oct;59(5):531-44. doi: 10.1016/s0034-7094(09)70078-9. Portuguese.
- Results publication: PubMed 16135349Singelyn FJ, Ferrant T, Malisse MF, Joris D. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):452-7. doi: 10.1016/j.rapm.2005.05.008.
- Results publication: 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.
- Results publication: PubMed 21526668Shafiq F, Hamid M, Samad K. Complications and interventions associated with epidural analgesia for postoperative pain relief in a tertiary care hospital. Middle East J Anaesthesiol. 2010 Oct;20(6):827-32.
- Results publication: PubMed 28656158Rasouli MR, Viscusi ER. Adductor Canal Block for Knee Surgeries: An Emerging Analgesic Technique. Arch Bone Jt Surg. 2017 May;5(3):131-132. No abstract available.
- Results publication: PubMed 35096534Kamel I, Ahmed MF, Sethi A. Regional anesthesia for orthopedic procedures: What orthopedic surgeons need to know. World J Orthop. 2022 Jan 18;13(1):11-35. doi: 10.5312/wjo.v13.i1.11. eCollection 2022 Jan 18.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We agree that all results and conclusion of this research will be used fully for other researchers
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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.
Tu Nguyen, Professor study director
Hanoi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PERICAPSULAR NERVE GROUP BLOCK COMBINED WITH LATERAL FEMORAL CUTANEOUS NERVE BLOCK in people with POSTOPERATIVE ANALGESIA, run by Hanoi Medical University at 1 site in Vietnam.
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 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 18 Sep 2023. 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 Vietnam. 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?
VAS score at rest and on movement (time frame: Time was recorded from initiation of catheterization or PCA insertion (H0) to after 72 hours (H72)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040879, which also lists 9 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 18 Sep 2023.