Postoperative Acute PainPhase 4NCT07171125
Liposomal Bupivacaine for Pain After Lumbar Fusion
A Phase 4 study testing Liposomal bupivacaine (local infiltration) and ropivacaine (local infiltration) in people with Postoperative Acute Pain and Lumbar Degenerative Diseases, run by Min Li at 1 site in China.
Trial summary
Spine surgery often causes severe postoperative pain. Currently, our hospital routinely uses ropivacaine for local infiltration analgesia (lasting 6-8 hours). This study evaluates liposomal bupivacaine, a novel long-acting local anesthetic providing up to 72 hours of pain relief, in patients undergoing posterior… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Acute Pain, Lumbar Degenerative Diseases
- What is being tested?
- Liposomal bupivacaine (local infiltration) and ropivacaine (local infiltration)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2025to 3 Mar 2026
- Phase
- Phase 4
- 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
- Age ≥18 years；
- ASA physical status class I-III；
- Scheduled for elective 1- or 2-level posterior lumbar surgery: Decompression (laminectomy/discectomy) and fusion with internal fixation
Who cannot join
- Chronic pain disorders requiring ≥30 mg oral morphine equivalents/day for >3 months.
- Pre-existing neurological deficits that may interfere with pain assessment.
- Hypersensitivity to any component of multimodal analgesia or local anesthetics (e.g., bupivacaine, ropivacaine).
- Acute systemic/local infection (e.g., surgical site infection, sepsis).
- Metastatic spinal malignancies (confirmed by imaging/histopathology).
- Pregnancy or lactation.
- Patient refusal after detailed protocol explanation.
- Other investigator-determined high-risk conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liposomal Bupivacaine for Acute Pain Management Following Posterior Lumbar Decompression and Fusion Surgery in Adults: A Prospective, Randomized Controlled Trial
Spine surgery often causes severe postoperative pain. Currently, our hospital routinely uses ropivacaine for local infiltration analgesia (lasting 6-8 hours). This study evaluates liposomal bupivacaine, a novel long-acting local anesthetic providing up to 72 hours of pain relief, in patients undergoing posterior lumbar spine surgery. Through a randomized controlled design, we will compare the two drugs' effects on pain control within 72 hours and opioid consumption. Both regimens are guideline-recommended and safe.
- Being tested
- Liposomal bupivacaine (local infiltration), ropivacaine (local infiltration)
- Keywords
- Liposomal bupivacaine, Local infiltration analgesia, Posterior lumbar fusion, Postoperative pain, Randomized controlled trial, Opioid-sparing
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaine (local infiltration)Drug
Patients will receive a pre-closure local infiltration of 266 mg liposomal bupivacaine (20 mL for single-level surgery; 30 mL for two-level surgery) combined with 25 mg bupivacaine hydrochloride (10 mL total volume). The drug will be injected bilateral into the paraspinal muscles and subcutaneous tissues prior to wound closure. This provides both immediate (bupivacaine HCl) and prolonged (liposomal) analgesia."
ropivacaine (local infiltration)Drug
Patients will receive 120 mg ropivacaine diluted to 30 mL (single-level) or 40 mL (two-level) with normal saline. The solution will be infiltrated bilateral into the paraspinal muscles and subcutaneous tissues using the same technique as the experimental arm, ensuring consistent injection depth and distribution.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | 266 mg liposomal bupivacaine + 25 mg bupivacaine HCl, local infiltration during closure Receives: Drug: Liposomal bupivacaine (local infiltration) |
| Ropivacaine Group | Active comparator | 120 mg ropivacaine, local infiltration during closure. Receives: Drug: ropivacaine (local infiltration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption within 72 hours postoperatively (converted to morphine milligram equivalents, MME)
Opioid doses will be converted to MME using the CDC standard conversion table
Measured: 72 hours postoperative
Secondary outcomes (18)
Postoperative pain intensity assessed by Numeric Rating Scale (NRS, 0-10) at rest and during movement (e.g., coughing/ambulation) at predefined timepoints: pre-PACU discharge, 4h, 8h, 24h, 48h, and 72h after surgery.
NRS ranges from 0 (no pain) to 10 (worst imaginable pain). Movement-associated pain will be assessed during standardized activities (e.g., coughing on command or first ambulation).All assessors will be trained to ensure consistent NRS measurement across timepoints.
Daytime assessments: Performed within ±30 minutes of scheduled timepoints
Nighttime adjustments:
Assessments falling between 21:00 (9:00 PM) and 07:00 (7:00 AM) will be deferred to 08:00 AM the following morning to avoid sleep disruption.
Original timepoints documented with annotations (e.g., "Scheduled: 02:00; Assessed: 08:00+1")
Measured: Immediately prior to PACU discharge，4 hours, 8 hours, 24 hours, 48 hours, and 72 hours after surgery.
Total postoperative morphine consumption via PCA
PCA settings will be standardized across all patients:
- Bolus dose: 1 mg morphine equivalent
- Lockout interval:10 minutes
- No background infusion.
Measured: Cumulative consumption recorded at 4 hours, 8 hours, 24 hours, 48 hours, and 72 hours after surgery
Total Postoperative Rescue Tramadol Consumption
Trigger Criteria: NRS >3 at rest despite PCA morphine (1mg bolus, 10min lockout).
Dosing Protocol: Tramadol 50mg IV/oral
Data Collection:
Cumulative tramadol consumption recorded at 4hours, 8hour, 24hours, 48hours, 72hours after surgery.
Convert oral to IV equivalent for analysis
Measured: From PCA initiation until 72 hours (Day3) postoperatively. Rescue tramadol consumption will be recorded at 4hours, 8hour, 24hours, 48hours, 72hours after surgery.
Sleep disturbance due to pain (binary scale)
Patients will report whether pain interfered with sleep during the previous night using a standardized binary scale:
- 0: No sleep disruption (pain did not awaken or prevent sleep)
- 1: Sleep disrupted (pain caused awakening or difficulty falling asleep).
Assessment Protocol:
Evaluated each morning at 8:00 AM by trained research staff Covers sleep quality during the preceding night (20:00-07:59) Delayed assessment for nighttime surgeries: If surgery ends after 18:00, first assessment deferred to 8:00 AM on postoperative Day 1
Measured: Postoperative Days 1 (24 hours), 2 (48 hours), and 3 (72 hours), with daily assessment window: 8:00-9:00 AM
Time to first independent ambulation
Definition: Hours from surgery end to first unassisted walking >5 meters
Measured: From surgery completion until event occurs, assessed up to 72 hours postoperatively
Immediate local anesthetic-related complications (0-2 hours)
All complications will be recorded and graded. Immediate events (0-2h):
- Local anesthetic systemic toxicity (LAST): CNS/CV symptoms (e.g., seizures, arrhythmias)
- Allergic reactions: urticaria, bronchospasm, anaphylaxis
Measured: From local anesthetic infiltration completion through 2 hours post-procedure.
Incidence of nausea/vomiting (PONV)
Graded by severity: 1=Mild (no rescue), 2=Moderate (required 1 antiemetic), 3=Severe (≥2 antiemetics or prolonged NPO).
Standardized Assessment Protocol at fixed timepoints:
Day 1: 0-24 hours postoperatively Day 2: 24-48 hours postoperatively Day 3: 48-72 hours postoperatively
Assessment window:
Performed daily at 08:00 AM for previous 24-hour period Evening surgeries (end time >18:00): First assessment at 08:00 AM on Day 1
Symptom tracking:
Nursing staff document all emetic episodes and antiemetic administrations in real-time
Measured: From surgery completion through 72 hours (Day 3) postoperatively, with interval reporting: 0-24 hours (Day 1), 24-48 hours (Day 2), 48-72 hours (Day 3).
Pruritus severity
Rated by patients: 0=None, 1=Mild (no treatment), 2=Moderate (topical therapy), 3=Severe (systemic treatment).
Measured: From surgery completion through 72 hours (Day 3) postoperatively, with interval analyses: 0-24 hours (Day 1)，24-48 hours (Day 2)，48-72 hours (Day 3)
Incidence of Postoperative Urinary Retention Requiring Catheterization
Definition \& Assessment Protocol:
Diagnostic Criteria: Bladder volume ≥600 mL (ultrasound-confirmed) + inability to void spontaneously.
Catheterization threshold: Pain (VAS ≥4) with bladder volume ≥600 mL, OR No voiding for 8 hours + bladder volume ≥400 mL.
Data Collection:
Event-driven assessments: Triggered by patient-reported symptoms. Maximum observation period: 72 hours (Day 3).
Measured: From surgery completion through 72 hours (Day 3) postoperatively, with planned intervals: 0-24 hours (Day 1), 24-48 hours (Day 2), 48-72 hours (Day 3).
Postoperative Sedation Levels Assessed by Ramsay Scale
Ramsay Scale:
- Patient anxious/agitated
- Cooperative/oriented
- Responds to commands only
- Asleep but brisk response to stimulus
- Sluggish response
- No response.
Scoring Direction: Higher scores indicate deeper sedation (1=inadequate, 6=excessive).
Clinical Thresholds:
Target range: RSS 2-4 (ERAS-recommended optimal sedation) Intervention triggers: RSS ≥5 (reduce sedation), RSS ≤1 (rescue analgesia)
Assessment Protocol
Fixed Timepoints:
4 hours (Postoperative Day 0) 8 hours (Postoperative Day 0) 24 hours (Postoperative Day 1) 48 hours (Postoperative Day 2) 72 hours (Postoperative Day 3)
Nighttime Adjustment:
Assessments between 21:00-07:00 deferred to 08:00 next morning Data Collection Window: ±30 minutes at each timepoint
Standardized Stimuli:
Verbal: "Open your eyes" at 70 dB Tactile: Shoulder shaking with 500g pressure
Measured: From anesthesia emergence until 72 hours postoperatively, at Fixed timepoints: 4 hours, 8 hours, 24 hours, 48 hours and 72 hours after surgery.
Incidence of Postoperative Delirium Assessed by 3D-CAM (3-Minute Diagnostic Interview for CAM-Defined Delirium)
3D-CAM assesses: 1) Acute onset, 2) Inattention, 3) Disorganized thinking, 4) Altered consciousness. Administered by trained research assistants blinded to group allocation.
Primary Assessment Points:
24 hours (Postoperative Day 1) 48 hours (Postoperative Day 2) 72 hours (Postoperative Day 3)
Evaluation Window:
± 30 min at each timepoint. Nighttime detections (21:00-07:00) formally assessed at 08:00 next morning
Measured: From anesthesia emergence through 72 hours postoperatively: Primary Assessment Points: 24 hours (Postoperative Day 1) 48 hours (Postoperative Day 2) 72 hours (Postoperative Day 3)
PCA demand attempts
Unit of Measure: Number of attempts
Measured: Counted over consecutive intervals: 0-4 hours, 4-8 hours, 8-24 hours, 24-48 hours, and 48-72 hours postoperatively
PCA delivery/demand ratio
Calculation: (Number of successful PCA deliveries / Number of PCA demand attempts) × 100
Measured: Calculated for each interval: 0-4hours, 4-8hours, 8-24hours, 24-48hhours, 48-72hours after surgery.
Time to first PCA attempt
Measured: Recorded from end of surgery until first PCA button press
Time to first tolerated oral intake
Definition: Hours from surgery end to first clear liquid intake (≥50 mL) without vomiting within 30 minutes
Measured: From PACU discharge until event occurs, assessed up to 48 hours postoperatively
Time to first bowel movement
Definition: Hours from surgery end to first flatus or defecation reported by patient
Measured: From surgery completion until event occurs, assessed up to 7 days postoperatively
Postoperative length of stay
Definition: Days from surgery end to hospital discharge (excluding preoperative days)
Measured: From surgery completion until discharge, assessed up to 14 days postoperatively
Delayed local anesthetic-related complications (24-72 hours)
Definition: Complications manifesting 24-72 hours postoperatively
Subcategories:
1.Wound Complications:
- Infection: CDC criteria (purulent drainage + ≥1: erythema, pain, swelling)
- Hematoma: Ultrasound-confirmed collection >5 mL + hemoglobin drop ≥1 g/dL
- Neurological Injury 2.Persistent deficit: Sensory/motor dysfunction beyond 72 hours Confirmed by: Day 3: Nerve conduction studies (amplitude reduction >50%). Day 7: EMG if symptoms persist
Assessment Schedule:
Fixed timepoints: 24h (Day 1), 48h (Day 2), 72h (Day 3) at 08:00 AM Symptom-driven: Any clinical suspicion triggers immediate evaluation
Measured: Any clinical suspicion triggers immediate evaluation from 24 hours (Day 1) through 72 hours (Day 3) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start20 Sep 2025
- Primary completion28 Feb 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Min Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Li, Peking University Third Hospital
- Investigators
- Min Li, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171125
- Sponsor's protocol ID
- M20250040
- Status last verified
- Jun 2026
- First submitted
- 27 Aug 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to local data protection regulations, but anonymized aggregate results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine for Acute Pain Management Following Posterior Lumbar Decompression and Fusion Surgery in Adults: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07171125
- Acronym / sponsor ID
- M20250040
- Keywords
- Liposomal bupivacaine, Local infiltration analgesia, Posterior lumbar fusion, Postoperative pain, Randomized controlled trial, Opioid-sparing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Min LiUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 12 Sep 2025 (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.
Spine surgery often causes severe postoperative pain. Currently, our hospital routinely uses ropivacaine for local infiltration analgesia (lasting 6-8 hours). This study evaluates liposomal bupivacaine, a novel long-acting local anesthetic providing up to 72 hours of pain relief, in patients undergoing posterior lumbar spine surgery. Through a randomized controlled design, we will compare the two drugs' effects on pain control within 72 hours and opioid consumption. Both regimens are guideline-recommended and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Drug: Liposomal bupivacaine (local infiltration)266 mg liposomal bupivacaine + 25 mg bupivacaine HCl, local infiltration during closure |
| Ropivacaine Group | Active comparator | Drug: ropivacaine (local infiltration)120 mg ropivacaine, local infiltration during closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years；
- ASA physical status class I-III；
- Scheduled for elective 1- or 2-level posterior lumbar surgery: Decompression (laminectomy/discectomy) and fusion with internal fixation
Key exclusion criteria (8 listed)
- Chronic pain disorders requiring ≥30 mg oral morphine equivalents/day for >3 months.
- Pre-existing neurological deficits that may interfere with pain assessment.
- Hypersensitivity to any component of multimodal analgesia or local anesthetics (e.g., bupivacaine, ropivacaine).
- Acute systemic/local infection (e.g., surgical site infection, sepsis).
- Metastatic spinal malignancies (confirmed by imaging/histopathology).
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 |
|---|---|---|
| Liposomal bupivacaine (local infiltration)Patients will receive a pre-closure local infiltration of 266 mg liposomal bupivacaine (20 mL for single-level surgery; 30 mL for two-level surgery) combined with 25 mg bupivacaine hydrochloride (10 mL total volume). The drug will be injected bilateral into the paraspinal muscles and subcutaneous tissues prior to wound closure. This provides both immediate (bupivacaine HCl) and prolonged (liposomal) analgesia." | Drug | Liposomal Bupivacaine Group |
| ropivacaine (local infiltration)Patients will receive 120 mg ropivacaine diluted to 30 mL (single-level) or 40 mL (two-level) with normal saline. The solution will be infiltrated bilateral into the paraspinal muscles and subcutaneous tissues using the same technique as the experimental arm, ensuring consistent injection depth and distribution. | Drug | Ropivacaine Group |
Primary outcome
Total opioid consumption within 72 hours postoperatively (converted to morphine milligram equivalents, MME)
Time frame: 72 hours postoperative
Opioid doses will be converted to MME using the CDC standard conversion table
18 secondary outcomes
Postoperative pain intensity assessed by Numeric Rating Scale (NRS, 0-10) at rest and during movement (e.g., coughing/ambulation) at predefined timepoints: pre-PACU discharge, 4h, 8h, 24h, 48h, and 72h after surgery.
Time frame: Immediately prior to PACU discharge，4 hours, 8 hours, 24 hours, 48 hours, and 72 hours after surgery.
Total postoperative morphine consumption via PCA
Time frame: Cumulative consumption recorded at 4 hours, 8 hours, 24 hours, 48 hours, and 72 hours after surgery
Total Postoperative Rescue Tramadol Consumption
Time frame: From PCA initiation until 72 hours (Day3) postoperatively. Rescue tramadol consumption will be recorded at 4hours, 8hour, 24hours, 48hours, 72hours after surgery.
Sleep disturbance due to pain (binary scale)
Time frame: Postoperative Days 1 (24 hours), 2 (48 hours), and 3 (72 hours), with daily assessment window: 8:00-9:00 AM
Time to first independent ambulation
Time frame: From surgery completion until event occurs, assessed up to 72 hours postoperatively
Immediate local anesthetic-related complications (0-2 hours)
Time frame: From local anesthetic infiltration completion through 2 hours post-procedure.
Incidence of nausea/vomiting (PONV)
Time frame: From surgery completion through 72 hours (Day 3) postoperatively, with interval reporting: 0-24 hours (Day 1), 24-48 hours (Day 2), 48-72 hours (Day 3).
Pruritus severity
Time frame: From surgery completion through 72 hours (Day 3) postoperatively, with interval analyses: 0-24 hours (Day 1)，24-48 hours (Day 2)，48-72 hours (Day 3)
Incidence of Postoperative Urinary Retention Requiring Catheterization
Time frame: From surgery completion through 72 hours (Day 3) postoperatively, with planned intervals: 0-24 hours (Day 1), 24-48 hours (Day 2), 48-72 hours (Day 3).
Postoperative Sedation Levels Assessed by Ramsay Scale
Time frame: From anesthesia emergence until 72 hours postoperatively, at Fixed timepoints: 4 hours, 8 hours, 24 hours, 48 hours and 72 hours after surgery.
Incidence of Postoperative Delirium Assessed by 3D-CAM (3-Minute Diagnostic Interview for CAM-Defined Delirium)
Time frame: From anesthesia emergence through 72 hours postoperatively: Primary Assessment Points: 24 hours (Postoperative Day 1) 48 hours (Postoperative Day 2) 72 hours (Postoperative Day 3)
PCA demand attempts
Time frame: Counted over consecutive intervals: 0-4 hours, 4-8 hours, 8-24 hours, 24-48 hours, and 48-72 hours postoperatively
PCA delivery/demand ratio
Time frame: Calculated for each interval: 0-4hours, 4-8hours, 8-24hours, 24-48hhours, 48-72hours after surgery.
Time to first PCA attempt
Time frame: Recorded from end of surgery until first PCA button press
Time to first tolerated oral intake
Time frame: From PACU discharge until event occurs, assessed up to 48 hours postoperatively
Time to first bowel movement
Time frame: From surgery completion until event occurs, assessed up to 7 days postoperatively
Postoperative length of stay
Time frame: From surgery completion until discharge, assessed up to 14 days postoperatively
Delayed local anesthetic-related complications (24-72 hours)
Time frame: Any clinical suspicion triggers immediate evaluation from 24 hours (Day 1) through 72 hours (Day 3) 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 1 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to local data protection regulations, but anonymized aggregate results will be published.
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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.
Min Li principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine (local infiltration) and ropivacaine (local infiltration) in people with Postoperative Acute Pain and Lumbar Degenerative Diseases, run by Min Li at 1 site in China.
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 8 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 1 Jul 2026. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 opioid consumption within 72 hours postoperatively (converted to morphine milligram equivalents, MME) (time frame: 72 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.