New shot could keep pain away longer after surgery
NCT ID NCT06574269
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests TLC590, an extended-release version of the numbing drug ropivacaine, to see how well it controls pain after different surgeries like bunion removal, hernia repair, breast augmentation, tummy tuck, and knee replacement. About 120 adults aged 18 to 70 will receive one of several doses. Researchers will measure how the drug moves through the body, its safety, and the best dose. The goal is to find a longer-lasting pain relief option that reduces the need for frequent pain medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TLC590 (ropivacaine extended-release injectable suspension)
- What this could lead to
- If successful, TLC590 could provide longer-lasting pain relief after surgery, reducing the need for frequent painkiller doses.
- What could go wrong
- This is an early Phase 2 study with only 120 participants, so results may not apply to everyone. The drug may cause side effects or not work better than existing options.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Aug 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 to 70 years
- 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.
Show the full entry requirements Hide the full entry requirements
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 to 70 years, inclusive. For the Part 2 breast augmentation surgical model, only females can be enrolled 3. Scheduled to undergo one of the following elective surgeries, with no additional procedures and be able to use the anesthesia regimen: 1. Unilateral first metatarsal bunionectomy (Cohort 1) 2. Laparoscopy-assisted open ventral hernia repair (Cohort 2 and 6) 3. Breast augmentation (Cohort 3 through 5) 4. Unilateral total knee arthroplasty (Cohort 7) 5. Abdominoplasty (tummy tuck) (Cohort 8) 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 for the duration of the study and for 30 days after study drug administration 6. Female subjects are eligible only if all the following apply: 1. Not pregnant with a negative serum pregnancy test at Screening and negative urine pregnancy test on Day 1 before surgery (pregnancy test not required for females of non-childbearing potential, defined as surgically sterile or post-menopausal) 2. Not lactating 3. Not planning to become pregnant during the study 4. If of childbearing potential, commits to the use of a highly effective method of birth control for the duration of the study and or at least 30 days after study drug administration 7. BMI \>18 \~ ≤39 kg/m2 Exclusion Criteria: 1. A clinically significant abnormal clinical laboratory test value 2. Evidence of a clinically significant 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 condition that has been assessed by the Investigator to be unsuitable for participation in the study 5. History of seizures or taking anticonvulsants during the Screening period 6. History of cardiac arrhythmia or taking Class III antiarrhythmic drugs including amiodarone, dofetilide, dronedarone, sotalol, or ibutilide during the Screening period 7. History of sleep apnea or on home CPAP treatment 8. History of hypersensitivity to ropivacaine, any other amide-type local anesthetic, propofol, hydromorphone, fentanyl, midazolam, acetaminophen, oxycodone, or morphine (or other opioids) 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, as assessed by the C-SSRS at Screening 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 (regularly drinks \>4 units of alcohol per day: 1 unit = 8 oz. beer, 3 oz. wine, or 1 oz. spirits) within 2 years prior to Screening 13. Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or non-prescribed drug or alcohol abuse at Screening or on Day 1 before surgery. Prescribed medication that is known to result in a positive drug test is allowed. Marijuana (medical or recreational) is not allowed 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 the previous 6 months prior to Screening 16. Is taking daily analgesics for longer than 4 days per week for a chronically painful condition during the Screening period. Not exclusionary if it is utilized for pain related to the total knee arthroplasty indication 17. Is receiving oxygen therapy during the Screening period 18. Use of any of the following medications within 5 half-lives prior to the study surgical procedure or as specified 19. Malignancy in the last 2 years prior to Screening, 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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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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First Surgical Hospital
RECRUITINGBellaire, Texas, 77401, United States
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Memorial Hermann Village
RECRUITINGHouston, Texas, 77043, United States
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