AnalgesiaTIPACKNCT05303233
IPACK or Selective Tibial Nerve Block for ACL Reconstruction With an Adductor Canal Block
A study testing Selective tibial nerve block and IPACK in people with Analgesia, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare the analgesic efficacy of the combination of an adductor canal and selective tibial nerve blocks versus adductor canal block and IPACK after ACL reconstruction under general anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- Selective tibial nerve block and IPACK
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2022to 14 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA score I-III
- 18 years or older
- Scheduled for elective primary ACL reconstruction
- Signature of consent form
Who cannot join
- Refusal or inability for informed consent
- Known allergies to ropivacaine, acetaminophen, ibuprofen, ketorolac, morphine, sufentanyl, ondansetron or dexamethason
- Secondary surgical revision
- Opioid treatment such as morphine, hydrocodone, hydromorphone, tramadol, methadone, fentanyl, buprenorphine or codeine
- Bleeding diathesis
- Neurological deficit
Show all 10Show fewer
- Known renal insufficiency (eGFR <45 ml/min)
- Known hepatic insufficiency (Child score B or C)
- Pregnancy or lactating
- Alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of IPACK Versus Selective Tibial Nerve Block in Patients Scheduled for Anterior Cruciate Ligament Reconstruction Under General Anaesthesia With an Adductor Canal Block: a Randomized Controlled Double-blinded Trial
The purpose of this study is to compare the analgesic efficacy of the combination of an adductor canal and selective tibial nerve blocks versus adductor canal block and IPACK after ACL reconstruction under general anaesthesia.
Read the detailed description
The hypothesis of this study is that a combined adductor canal and selective tibial nerve block provides better analgesia than a combined adductor canal block and IPACK in patients undergoing anterior cruciate ligament reconstruction.
This randomized controlled trial will include two groups: an adductor canal block plus IPACK group (group IPACK) and an adductor canal block plus tibial selective nerve block group (group TIBIAL). After written informed consent, patients will be allocated to one of the groups, following a computer-generated list of randomization.
Prior to surgery, all patients will have an adductor canal block with 20ml of ropivacaine 0.75%. In group TIBIAL the patient will receive in addition a selective tibial nerve block with 5 ml of ropivacaine 0.75%. In group IPACK the patient will receive in addition an IPACK with 20ml of ropivacaine 0.2%. In both groups, patients will have the surgery under general anaesthesia with a multimodal analgesic regimen inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg.
After surgery, all patients will be prescribed an iv patient-controlled analgesia (PCA) of morphine (boluses of 2 mg available every 10 min, maximum of 40 mg every 4 hours) along with oral acetaminophen (1000 mg every 6 h) and oral ibuprofen (400 mg every 8 hours). Oral ondansetron 4 mg every 8 hours will be available on request in case of nausea or vomiting.
The primary outcome will be the cumulative iv morphine consumption at 24 h postoperatively. Secondary outcomes will include pain- and functional-related outcomes. Pain-related outcomes include cumulative morphine consumption at 2h and 48h postoperatively, rest and dynamic pain scores and rate of PONV at 2 h, 24 h and 48 h postoperatively. Early functional-related outcomes include range of motion, strength and walking distance at 24 h and 48 h postoperatively. Late functional-related outcomes include range of motion, strength, hop distance, agility test, Y balance test, Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) and International Knee Documentation Committee Scale (IKDC) at 4 and 8 months postoperatively.
- Conditions
- Analgesia
- Being tested
- Selective tibial nerve block, IPACK
- Keywords
- Regional anesthesia, Selective tibial nerve block, IPACK, Anterior cruciate ligament reconstruction, Multimodal analgesia, Local anesthetics
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective tibial nerve blockProcedure or surgery
The selective tibial nerve block will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position at the popliteal crease to visualize the popliteal artery and the tibial nerve in short axis. A 21-gauge 50mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound bean from a medial to lateral direction. Once the needle tip is adjacent to the tibial nerve, 5 ml of ropivacaine 0.75% will be injected to achieve an adequate spread of local anaesthetics around the nerve.
IPACKProcedure or surgery
The IPACK will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position proximal to the popliteal crease to visualize the popliteal artery in short axis. A 21-gauge 100 mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound beam, in a lateral to medial direction, between the popliteal artery and the posterior capsule, where twenty mL of ropivacaine 0.2% will be injected under ultrasound guidance. The distribution of local anaesthetics will be observed above the posterior capsule.
| Study group | Role | What they receive |
|---|---|---|
| TIBIAL group | Experimental | All patients allocated to the TIBIAL group will receive an adductor canal block with 20ml of ropivacaine 0.75% and a selective tibial nerve block with 5 ml of ropivacaine 0.75% prior to surgery, Receives: Procedure: Selective tibial nerve block |
| IPACK group | Active comparator | All patients allocated to the IPACK group will receive an adductor canal block with 20ml of ropivacaine 0.75% and an IPACK with 20ml of ropivacaine 0.2% prior to surgery. Receives: Procedure: IPACK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intravenous morphine consumption
Consumption in mg
Measured: 1 day postoperatively
Secondary outcomes (13)
Total intravenous morphine consumption
Consumption in mg
Measured: 2 hours and 2 days postoperatively
Resting and dynamic pain score
Numeric Rating Scale (NRS), 0-10 where 0 is no pain and 10 is the worst pain imaginable
Measured: 2 hours, 1 day and 2 days postoperatively
Incidence of postoperative nausea and vomiting
Presence of nausea and vomiting in the postoperative period
Measured: 2 hours, 1 day and 2 days postoperatively
Range of motion
Joint motion in degrees
Measured: 1 day and 2 days postoperatively
Quadriceps strength
Ordinal scale of 1-5, with 5 being the maximal developed strength compared with the opposite side
Measured: 1 day and 2 days postoperatively
Walking distance
Distance in meters
Measured: 1 day and 2 days postoperatively
Range of motion
Joint motion in degrees
Measured: 4 months and 8 months postoperatively
Concentric quadriceps strength and concentric hamstring strength
Percentage of strength as compared with the opposite leg
Measured: 4 months and 8 months postoperatively
Single hop distance, triple hop distance and crossover triple hop distance
Percentage of distance as compared with the opposite leg
Measured: 4 months and 8 months postoperatively
Agility test
Time in second
Measured: 4 months and 8 months postoperatively
Y balance test
Distance in cm
Measured: 4 months and 8 months postoperatively
Anterior Cruciate Ligament Return to Sport After Injury Scale score
Score in percentage
Measured: 4 months and 8 months postoperatively
International Knee Documentation Committee Scale score
Score in percentage
Measured: 4 months and 8 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 May 2022
- Primary completion14 Nov 2024
- Study completion14 Jul 2025
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 AnalgesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eric Albrecht, M.D., Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303233
- Sponsor's protocol ID
- CER-VD 2021-02474
- Acronym
- TIPACK
- Status last verified
- Jul 2025
- First submitted
- 21 Mar 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chuaychoosakoon C, Parinyakhup W, Wiwatboworn A, Purngpiputtrakul P, Wanasitchaiwat P, Boonriong T. Comparing post-operative pain between single bundle and double bundle anterior cruciate ligament reconstruction: a retrospective study. BMC Musculoskelet Disord. 2021 Sep 3;22(1):753. doi: 10.1186/s12891-021-04635-5.
PubMed 34479511Smith JH, Belk JW, Kraeutler MJ, Houck DA, Scillia AJ, McCarty EC. Adductor Canal Versus Femoral Nerve Block after Anterior Cruciate Ligament Reconstruction: A Systematic Review of Level I Randomized Controlled Trials Comparing Early Postoperative Pain, Opioid Requirements, and Quadriceps Strength. Arthroscopy. 2020 Jul;36(7):1973-1980. doi: 10.1016/j.arthro.2020.03.040. Epub 2020 Apr 18.
PubMed 32315764Jansen TK, Miller BE, Arretche N, Pellegrini JE. Will the addition of a sciatic nerve block to a femoral nerve block provide better pain control following anterior cruciate ligament repair surgery? AANA J. 2009 Jun;77(3):213-8.
PubMed 19645171Silverman ER, Vydyanathan A, Gritsenko K, Shaparin N, Singh N, Downie SA, Kosharskyy B. The Anatomic Relationship of the Tibial Nerve to the Common Peroneal Nerve in the Popliteal Fossa: Implications for Selective Tibial Nerve Block in Total Knee Arthroplasty. Pain Res Manag. 2017;2017:7250181. doi: 10.1155/2017/7250181. Epub 2017 Feb 2.
PubMed 28260964Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.
PubMed 31130273Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.
PubMed 34039734van der Wal M, Lang SA, Yip RW. Transsartorial approach for saphenous nerve block. Can J Anaesth. 1993 Jun;40(6):542-6. doi: 10.1007/BF03009739.
PubMed 8403121
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of IPACK Versus Selective Tibial Nerve Block in Patients Scheduled for Anterior Cruciate Ligament Reconstruction Under General Anaesthesia With an Adductor Canal Block: a Randomized Controlled Double-blinded Trial
- ClinicalTrials.gov ID
- NCT05303233
- Acronym / sponsor ID
- TIPACK / CER-VD 2021-02474
- Conditions
- Analgesia
- Keywords
- Regional anesthesia, Selective tibial nerve block, IPACK, Anterior cruciate ligament reconstruction, Multimodal analgesia, Local anesthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 31 Mar 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.
The purpose of this study is to compare the analgesic efficacy of the combination of an adductor canal and selective tibial nerve blocks versus adductor canal block and IPACK after ACL reconstruction under general anaesthesia.
Detailed description
The hypothesis of this study is that a combined adductor canal and selective tibial nerve block provides better analgesia than a combined adductor canal block and IPACK in patients undergoing anterior cruciate ligament reconstruction.
This randomized controlled trial will include two groups: an adductor canal block plus IPACK group (group IPACK) and an adductor canal block plus tibial selective nerve block group (group TIBIAL). After written informed consent, patients will be allocated to one of the groups, following a computer-generated list of randomization.
Prior to surgery, all patients will have an adductor canal block with 20ml of ropivacaine 0.75%. In group TIBIAL the patient will receive in addition a selective tibial nerve block with 5 ml of ropivacaine 0.75%. In group IPACK the patient will receive in addition an IPACK with 20ml of ropivacaine 0.2%. In both groups, patients will have the surgery under general anaesthesia with a multimodal analgesic regimen inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg.
After surgery, all patients will be prescribed an iv patient-controlled analgesia (PCA) of morphine (boluses of 2 mg available every 10 min, maximum of 40 mg every 4 hours) along with oral acetaminophen (1000 mg every 6 h) and oral ibuprofen (400 mg every 8 hours). Oral ondansetron 4 mg every 8 hours will be available on request in case of nausea or vomiting.
The primary outcome will be the cumulative iv morphine consumption at 24 h postoperatively. Secondary outcomes will include pain- and functional-related outcomes. Pain-related outcomes include cumulative morphine consumption at 2h and 48h postoperatively, rest and dynamic pain scores and rate of PONV at 2 h, 24 h and 48 h postoperatively. Early functional-related outcomes include range of motion, strength and walking distance at 24 h and 48 h postoperatively. Late functional-related outcomes include range of motion, strength, hop distance, agility test, Y balance test, Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) and International Knee Documentation Committee Scale (IKDC) at 4 and 8 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIBIAL group | Experimental | Procedure: Selective tibial nerve blockAll patients allocated to the TIBIAL group will receive an adductor canal block with 20ml of ropivacaine 0.75% and a selective tibial nerve block with 5 ml of ropivacaine 0.75% prior to surgery, |
| IPACK group | Active comparator | Procedure: IPACKAll patients allocated to the IPACK group will receive an adductor canal block with 20ml of ropivacaine 0.75% and an IPACK with 20ml of ropivacaine 0.2% prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA score I-III
- 18 years or older
- Scheduled for elective primary ACL reconstruction
- Signature of consent form
Key exclusion criteria (10 listed)
- Refusal or inability for informed consent
- Known allergies to ropivacaine, acetaminophen, ibuprofen, ketorolac, morphine, sufentanyl, ondansetron or dexamethason
- Secondary surgical revision
- Opioid treatment such as morphine, hydrocodone, hydromorphone, tramadol, methadone, fentanyl, buprenorphine or codeine
- Bleeding diathesis
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 |
|---|---|---|
| Selective tibial nerve blockThe selective tibial nerve block will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position at the popliteal crease to visualize the popliteal artery and the tibial nerve in short axis. A 21-gauge 50mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound bean from a medial to lateral direction. Once the needle tip is adjacent to the tibial nerve, 5 ml of ropivacaine 0.75% will be injected to achieve an adequate spread of local anaesthetics around the nerve. | Procedure or surgery | TIBIAL group |
| IPACKThe IPACK will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position proximal to the popliteal crease to visualize the popliteal artery in short axis. A 21-gauge 100 mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound beam, in a lateral to medial direction, between the popliteal artery and the posterior capsule, where twenty mL of ropivacaine 0.2% will be injected under ultrasound guidance. The distribution of local anaesthetics will be observed above the posterior capsule. | Procedure or surgery | IPACK group |
Primary outcome
Total intravenous morphine consumption
Time frame: 1 day postoperatively
Consumption in mg
13 secondary outcomes
Total intravenous morphine consumption
Time frame: 2 hours and 2 days postoperatively
Resting and dynamic pain score
Time frame: 2 hours, 1 day and 2 days postoperatively
Incidence of postoperative nausea and vomiting
Time frame: 2 hours, 1 day and 2 days postoperatively
Range of motion
Time frame: 1 day and 2 days postoperatively
Quadriceps strength
Time frame: 1 day and 2 days postoperatively
Walking distance
Time frame: 1 day and 2 days postoperatively
Range of motion
Time frame: 4 months and 8 months postoperatively
Concentric quadriceps strength and concentric hamstring strength
Time frame: 4 months and 8 months postoperatively
Single hop distance, triple hop distance and crossover triple hop distance
Time frame: 4 months and 8 months postoperatively
Agility test
Time frame: 4 months and 8 months postoperatively
Y balance test
Time frame: 4 months and 8 months postoperatively
Anterior Cruciate Ligament Return to Sport After Injury Scale score
Time frame: 4 months and 8 months postoperatively
International Knee Documentation Committee Scale score
Time frame: 4 months and 8 months postoperatively
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 8 Aug 2025.
- Background: PubMed 34479511Chuaychoosakoon C, Parinyakhup W, Wiwatboworn A, Purngpiputtrakul P, Wanasitchaiwat P, Boonriong T. Comparing post-operative pain between single bundle and double bundle anterior cruciate ligament reconstruction: a retrospective study. BMC Musculoskelet Disord. 2021 Sep 3;22(1):753. doi: 10.1186/s12891-021-04635-5.
- Background: PubMed 32315764Smith JH, Belk JW, Kraeutler MJ, Houck DA, Scillia AJ, McCarty EC. Adductor Canal Versus Femoral Nerve Block after Anterior Cruciate Ligament Reconstruction: A Systematic Review of Level I Randomized Controlled Trials Comparing Early Postoperative Pain, Opioid Requirements, and Quadriceps Strength. Arthroscopy. 2020 Jul;36(7):1973-1980. doi: 10.1016/j.arthro.2020.03.040. Epub 2020 Apr 18.
- Background: PubMed 19645171Jansen TK, Miller BE, Arretche N, Pellegrini JE. Will the addition of a sciatic nerve block to a femoral nerve block provide better pain control following anterior cruciate ligament repair surgery? AANA J. 2009 Jun;77(3):213-8.
- Background: PubMed 28260964Silverman ER, Vydyanathan A, Gritsenko K, Shaparin N, Singh N, Downie SA, Kosharskyy B. The Anatomic Relationship of the Tibial Nerve to the Common Peroneal Nerve in the Popliteal Fossa: Implications for Selective Tibial Nerve Block in Total Knee Arthroplasty. Pain Res Manag. 2017;2017:7250181. doi: 10.1155/2017/7250181. Epub 2017 Feb 2.
- Background: PubMed 31130273Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.
- Background: PubMed 34039734Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.
- Background: PubMed 8403121van der Wal M, Lang SA, Yip RW. Transsartorial approach for saphenous nerve block. Can J Anaesth. 1993 Jun;40(6):542-6. doi: 10.1007/BF03009739.
- 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.
Eric Albrecht, M.D. principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective tibial nerve block and IPACK in people with Analgesia, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 4 inclusion and 10 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 8 Aug 2025. 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 Switzerland. 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?
Total intravenous morphine consumption (time frame: 1 day postoperatively). 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 NCT05303233, 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 8 Aug 2025.