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Study of TLC590 for Postsurgical Pain After Bunion Surgery

This study is testing a new pain medication called TLC590 (Ropivacaine Extended-Release Injectable Suspension) for people who have pain after bunion surgery. Researchers want to see if TLC590 works better than Liposomal Bupivacaine or a saline placebo (an inactive substance like salt water). You might be able to join if you are 18 or older, are having your first bunion surgery on one foot, and meet certain health criteria. The main goal is to measure how much pain relief participants get for the first 72 hours (3 days) after surgery. The current recruitment status is unclear.

Study design
This is a Phase 3, randomized, double-blind study with about 304 participants. It compares TLC590 to another pain medication and a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Pain intensity will be measured for 72 hours (3 days) after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07222748

A Study of TLC590 for Postsurgical Pain Following Bunionectomy

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
TLC Biopharmaceuticals, Inc.
~304 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:TLC590Liposomal BupivacaineSaline Placebo

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 72 hours

Conditions

Postoperative Pain

Explore related trials

BunionPost-Operative Pain

Where it's being run

4 sites across 2 states
Texas3
Florida1

Study leadership

  • Tien-Tzu Tai, MD · STUDY_DIRECTOR · Taiwan Liposome Company

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • 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.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.