Postoperative PainPhase 3NCT07222748
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
A Phase 3 study testing TLC590 and Liposomal Bupivacaine in people with Postoperative Pain, run by TLC Biopharmaceuticals, Inc. at 4 sites in United States.
Trial summary
This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via local infiltration in adult subjects following bunionectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- TLC590 and Liposomal Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Nov 2025to Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Able and willing to provide written informed consent.
- Male or female aged 18 years or older (inclusive).
- Scheduled to undergo a primary unilateral, transpositional first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia.
- ASA Physical Status Classification of 1 or 2.
- Male subjects must be either biologically or surgically sterile or commit to the use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence.
- Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, or committing to the use of a highly effective method of birth control.
- BMI >18 ~ ≤39 kg/m2, with a minimum weight of 50 kg.
Who cannot join
- An abnormal clinical laboratory test value.
- Evidence of a clinically significant abnormal 12-lead ECG.
- History of orthostatic hypotension, syncope, or other syncopal attacks.
- History or any clinical manifestation of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other conditions that have been assessed by the Investigator to make the subject unsuitable for participation in the study.
- History of seizures or taking anticonvulsants.
- History of cardiac arrhythmia or taking Class III antiarrhythmic drugs.
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- History of sleep apnea or at-home CPAP treatment.
- History of hypersensitivity to ropivacaine, bupivacaine, any other amide-type local anesthetic, or any other trial-required medications.
- History of severe or refractory PONV due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer, deemed clinically significant by the Investigator.
- Any lifetime history of a suicidal attempt or any suicidal behavior.
- History or positive test results of HIV, HCV, or HBV.
- History or current report of substance abuse including illicit drug abuse and/or alcohol abuse.
- Positive results on the urine drug screen or alcohol breath test.
- Pre-existing concurrent acute, or chronic painful restrictive/physical condition that may confound postoperative pain assessments or is expected to require analgesic treatment during the study.
- Has known or suspected daily use of opioids for longer than 4 days per week within 6 months.
- Use of daily analgesics for longer than 4 days per week for a chronically painful condition.
- Is receiving oxygen therapy.
- Use of any of the pre-specified medications prior to the study surgical procedure or as specified.
- Malignancy in the past 2 years, except for non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- Personal or family history of malignant hyperthermia.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
First Surgical Hospital
Bellaire, Texas, 77401
Memorial Hermann Village
Houston, Texas, 77043
Clinical Pharmacology of Miami
Miami, Florida, 33172
Endeavor Clinical Trials
San Antonio, Texas, 78240
About this study
Official title: A Phase 3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via local infiltration in adult subjects following bunionectomy.
- Conditions
- Postoperative Pain
- Being tested
- TLC590, Liposomal Bupivacaine, Saline Placebo
- Keywords
- Bunion, Bunionectomy, Bunion surgery, Postoperative pain
- Medical subject headings
- Pain, Postoperative, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC590Drug
TLC590 (Ropivacaine Extended-Release Injectable Suspension)
Liposomal BupivacaineDrug
Bupivacaine Liposome Injectable Suspension
Saline PlaceboDrug
Normal Saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| TLC590 | Experimental | Not described Receives: Drug: TLC590 |
| Liposomal Bupivacaine | Active comparator | Not described Receives: Drug: Liposomal Bupivacaine |
| Saline Placebo | Placebo comparator | Not described Receives: Drug: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Saline Placebo.
Pain intensity is measured using an 11-point Numeric Rating Scale (NRS) (0-10), where 0 represents "no pain" and 10 represents "worst pain imaginable", and higher scores indicate worse pain.
Measured: 72 hours
Secondary outcomes (5)
Proportion of subjects who are opioid-free for TLC590 compared with Saline Placebo.
Measured: 72 hours
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Bupivacaine Liposome.
Pain intensity is measured using an 11-point Numeric Rating Scale (NRS) (0-10), where 0 represents "no pain" and 10 represents "worst pain imaginable", and higher scores indicate worse pain.
Measured: 72 hours
Mean Total Postoperative Opioid Consumption for TLC590 Compared with Saline Placebo
Measured: 72 hours
Proportion of subjects who are opioid-free for TLC590 compared with Bupivacaine Liposome.
Measured: 72 hours
Mean Total Postoperative Opioid Consumption for TLC590 Compared with Bupivacaine Liposome.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start17 Nov 2025
- Primary completion12 Jun 2026
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- TLC Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tien-Tzu Tai, MD, Study director, Taiwan Liposome Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222748
- Sponsor's protocol ID
- TLC590A3004
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
- ClinicalTrials.gov ID
- NCT07222748
- Acronym / sponsor ID
- TLC590A3004
- Conditions
- Postoperative Pain
- Keywords
- Bunion, Bunionectomy, Bunion surgery, Postoperative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 304 participants (actual)
- Lead sponsor
- TLC Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 Oct 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.
This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via local infiltration in adult subjects following bunionectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TLC590 | Experimental | Drug: TLC590 |
| Liposomal Bupivacaine | Active comparator | Drug: Liposomal Bupivacaine |
| Saline Placebo | Placebo comparator | Drug: Saline Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to provide written informed consent.
- Male or female aged 18 years or older (inclusive).
- Scheduled to undergo a primary unilateral, transpositional first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia.
- ASA Physical Status Classification of 1 or 2.
- Male subjects must be either biologically or surgically sterile or commit to the use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence.
Key exclusion criteria (20 listed)
- An abnormal clinical laboratory test value.
- Evidence of a clinically significant abnormal 12-lead ECG.
- History of orthostatic hypotension, syncope, or other syncopal attacks.
- History or any clinical manifestation of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other conditions that have been assessed by the Investigator to make the subject unsuitable for participation in the study.
- History of seizures or taking anticonvulsants.
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 |
|---|---|---|
| TLC590TLC590 (Ropivacaine Extended-Release Injectable Suspension) | Drug | TLC590 |
| Liposomal BupivacaineBupivacaine Liposome Injectable Suspension | Drug | Liposomal Bupivacaine |
| Saline PlaceboNormal Saline 0.9% | Drug | Saline Placebo |
Primary outcome
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Saline Placebo.
Time frame: 72 hours
Pain intensity is measured using an 11-point Numeric Rating Scale (NRS) (0-10), where 0 represents "no pain" and 10 represents "worst pain imaginable", and higher scores indicate worse pain.
5 secondary outcomes
Proportion of subjects who are opioid-free for TLC590 compared with Saline Placebo.
Time frame: 72 hours
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Bupivacaine Liposome.
Time frame: 72 hours
Mean Total Postoperative Opioid Consumption for TLC590 Compared with Saline Placebo
Time frame: 72 hours
Proportion of subjects who are opioid-free for TLC590 compared with Bupivacaine Liposome.
Time frame: 72 hours
Mean Total Postoperative Opioid Consumption for TLC590 Compared with Bupivacaine Liposome.
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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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.
Tien-Tzu Tai, MD study director
Taiwan Liposome Company
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TLC590 and Liposomal Bupivacaine in people with Postoperative Pain, run by TLC Biopharmaceuticals, Inc. at 4 sites in United States.
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 7 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 2 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 4 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Saline Placebo. (time frame: 72 hours). 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 2 Jul 2026.