New injection could cut opioid use after bunion surgery
NCT ID NCT07222748
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a new medicine called TLC590 for pain after bunionectomy (foot bone surgery). About 300 adults will receive either TLC590, a standard painkiller, or a placebo. The goal is to see if TLC590 reduces pain and the need for opioid painkillers in the first 72 hours after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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304 people
The number who actually took part.
- Started
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Nov 2025
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical Pharmacology of Miami
Miami, Florida, 33172, United States
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Endeavor Clinical Trials
San Antonio, Texas, 78240, United States
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First Surgical Hospital
Bellaire, Texas, 77401, United States
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Memorial Hermann Village
Houston, Texas, 77043, United States
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Other studies related to the condition(s) this trial covers.
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