TLC590 (long-acting numbing medicine) for pain after bunion surgery

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 trial tests whether a long-acting local numbing medicine (TLC590) injected into the surgical site can reduce pain for adults after bunionectomy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Taiwan Liposome Company (Industry-sponsored)
• Locations: 4 sites (Miami, Florida and 3 other locations)
• Trial ID: NCT07222748 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, double-blind study comparing TLC590 to an active liposomal bupivacaine comparator and to saline placebo, delivered by local infiltration after a primary unilateral transpositional first metatarsal bunionectomy. Adults ASA class 1–2 with BMI between >18 and ≤39 kg/m2 who undergo osteotomy and internal fixation under regional anesthesia are randomized to receive one of the three injections at the surgical site. Pain, safety, and likely opioid consumption are followed postoperatively under blinded conditions to determine analgesic efficacy and adverse events. The trial is conducted at several U.S. surgical and clinical pharmacology sites.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) scheduled for a primary unilateral transpositional first metatarsal bunionectomy with osteotomy and internal fixation, who are ASA class 1 or 2, meet the BMI and weight limits, and can give informed consent and comply with study procedures.

Not a fit: Patients with abnormal lab results or clinically significant ECG abnormalities, a history of orthostatic hypotension or syncope, pregnant or lactating people, those having revision or bilateral procedures, or patients outside the BMI/weight or ASA criteria are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, TLC590 could provide longer-lasting local pain relief after bunionectomy and reduce the need for opioid pain medicines.

How similar studies have performed: Other long-acting liposomal bupivacaine formulations have produced mixed but often positive results for reducing postoperative pain and opioid use, with effectiveness varying by surgical procedure and study design.

Eligibility criteria

Inclusion Criteria:

1. Able and willing to provide written informed consent.
2. Male or female aged 18 years or older (inclusive).
3. Scheduled to undergo a primary unilateral, transpositional first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia.
4. ASA Physical Status Classification of 1 or 2.
5. 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.
6. 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.
7. BMI \>18 \~ ≤39 kg/m2, with a minimum weight of 50 kg.

Exclusion Criteria:

1. An abnormal clinical laboratory test value.
2. Evidence of a clinically significant abnormal 12-lead ECG.
3. History of orthostatic hypotension, syncope, or other syncopal attacks.
4. 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.
5. History of seizures or taking anticonvulsants.
6. History of cardiac arrhythmia or taking Class III antiarrhythmic drugs.
7. History of sleep apnea or at-home CPAP treatment.
8. History of hypersensitivity to ropivacaine, bupivacaine, any other amide-type local anesthetic, or any other trial-required medications.
9. 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.
10. Any lifetime history of a suicidal attempt or any suicidal behavior.
11. History or positive test results of HIV, HCV, or HBV.
12. History or current report of substance abuse including illicit drug abuse and/or alcohol abuse.
13. Positive results on the urine drug screen or alcohol breath test.
14. 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.
15. Has known or suspected daily use of opioids for longer than 4 days per week within 6 months.
16. Use of daily analgesics for longer than 4 days per week for a chronically painful condition.
17. Is receiving oxygen therapy.
18. Use of any of the pre-specified medications prior to the study surgical procedure or as specified.
19. 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.
20. Personal or family history of malignant hyperthermia.

Where this trial is running

Miami, Florida and 3 other locations

• Clinical Pharmacology of Miami — Miami, Florida, United States (Not_yet_recruiting)
• First Surgical Hospital — Bellaire, Texas, United States (Recruiting)
• Memorial Hermann Village — Houston, Texas, United States (Recruiting)
• Endeavor Clinical Trials — San Antonio, Texas, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Jack Chang

Conditions Postoperative Pain; Bunion; Bunionectomy; Bunion surgery; Postoperative pain