TLC590 for Postoperative Pain

Recruiting at 1 trial location

Overseen By Grace Tsao

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Taiwan Liposome Company

Must not be taking: Anticonvulsants, Antiarrhythmics, Opioids, others

Disqualifiers: Seizures, Cardiac arrhythmia, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TLC590 (Ropivacaine Extended-Release Injectable Suspension) to evaluate its effectiveness in managing pain after surgeries such as bunion removal, hernia repair, breast augmentation, tummy tuck, and knee replacement. The main goal is to determine the safest dose of TLC590 and compare its effects to ropivacaine, a common pain treatment. Individuals scheduled for one of these surgeries, without additional procedures, and who can adhere to the anesthesia plan, may be suitable for the trial. The study aims to enhance post-surgery pain management by potentially offering a new alternative to existing pain relief methods. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications, especially those related to seizures, cardiac arrhythmias, and daily analgesics, may affect eligibility, so it's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that TLC590 is likely to be safe for humans?

Research has shown that TLC590 is promising for managing post-surgical pain. Studies have found that TLC590 provides quick pain relief lasting up to 72 hours. Importantly, it appears to have a lower risk of heart and brain side effects compared to bupivacaine, a common pain medication.

Patients who used TLC590 after bunion surgery reported good results and did not experience significant side effects, indicating it is well-tolerated. This is encouraging as researchers continue testing TLC590 in various surgeries.

Although the current trial remains in the early stages, earlier research suggests the drug is safe. These trials are carefully monitored to ensure the drug's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TLC590 for postoperative pain because it offers a new approach that could enhance pain management. Unlike standard options like opioids or local anesthetics such as bupivacaine and ropivacaine, which can have significant side effects or limited duration, TLC590 is a long-acting, sustained-release formulation. This means it can provide extended pain relief with potentially fewer doses and side effects. The unique delivery system allows for a gradual release of the medication, which could improve patient comfort and recovery times significantly.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

Research has shown that TLC590, which participants in this trial may receive, may help manage pain after surgery. In earlier studies, TLC590 provided quick and long-lasting pain relief for up to 72 hours, surpassing the duration of some common treatments like bupivacaine. It may also pose fewer risks of heart and nervous system side effects. TLC590 is designed to provide steady and effective pain relief after surgeries, such as bunion removal. Early results suggest it could be a good option for easing post-surgery pain, making recovery more comfortable. ^{2 3 4 5 6}

Who Is on the Research Team?

Tien-Tzu Tai, MD

Principal Investigator

Taiwan Liposome Company

Are You a Good Fit for This Trial?

This trial is for individuals undergoing certain surgeries (like bunionectomy, hernia repair, breast augmentation, tummy tuck, or knee replacement) who need pain management post-operation. Specific eligibility criteria are not provided here.

Inclusion Criteria

BMI >18 and ≤39 kg/m2

I am not pregnant and follow the required birth control measures.

Able and willing to provide written informed consent

Exclusion Criteria

I have not had cancer in the last 2 years, with some exceptions.

History of suicidal behavior or positive test results for specific infections

I have a history of irregular heartbeats or take medication for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TLC590 or ropivacaine injection across various surgical models to evaluate pharmacokinetics, pharmacodynamics, and safety

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TLC590

Trial Overview The study is testing TLC590 to see how it's processed in the body and its safety across different surgeries. It compares TLC590 with a standard pain relief injection called ropivacaine to find the highest dose patients can tolerate without severe side effects.

How Is the Trial Designed?

Group I: Part 3, Cohort 8 Experimental Treatment 1 Intervention

Abdominoplasty: The MTD of TLC590

Group II: Part 3, Cohort 7 Experimental Treatment 1 Intervention

Total Knee Arthroplasty: The MTD of TLC590

Group III: Part 3, Cohort 6 Experimental Treatment 1 Intervention

Laparoscopy-assisted Open Ventral Hernia: The MTD of TLC590

Group IV: Part 2, Cohort 5 Experimental Treatment 1 Intervention

Breast Augmentation: TLC590 with the SMC-suggested dose

Group V: Part 2, Cohort 4 Experimental Treatment 2 Interventions

Breast Augmentation: TLC590 or Ropivacaine

Group VI: Part 2, Cohort 3 Experimental Treatment 2 Interventions

Breast Augmentation: TLC590 or Ropivacaine

Group VII: Part 1, Cohort 2 Experimental Treatment 1 Intervention

Laparoscopy-assisted Open Ventral Hernia: TLC590

Group VIII: Part 1, Cohort 1 Experimental Treatment 1 Intervention

Bunionectomy: Increasing dose cohorts for TLC590

Who Is Running the Clinical Trial?

Taiwan Liposome Company

Lead Sponsor

Trials

19

Recruited

1,800+

Published Research Related to This Trial

In a study involving 81 patients, infiltration of ropivacaine did not significantly reduce acute pain after breast cancer surgery compared to a placebo, as measured by pain scores and medication use.

One year later, there was no difference in the incidence of chronic pain between the ropivacaine and placebo groups, indicating that ropivacaine scar infiltration was ineffective for both acute and chronic pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ropivacaine infiltration during breast cancer surgery: postoperative acute and chronic pain effect]. Baudry, G., Steghens, A., Laplaza, D., et al.[2022]

In a pilot study involving postoperative patients after total knee arthroplasty, an intraarticular injection of 100 mL of 0.2% ropivacaine showed a trend towards lower pain scores compared to placebo, but this was not statistically significant.

Despite the initial trend in pain reduction, the use of ropivacaine did not lead to a significant decrease in narcotic usage, indicating that it may not be an effective standalone treatment for pain management after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of intraarticular ropivacaine for pain management immediately following total knee arthroplasty. Rosen, AS., Colwell, CW., Pulido, PA., et al.[2021]

A new long-acting formulation of ropivacaine was developed using a self-assembling peptide, which allows for a slow release of the drug, significantly extending its analgesic effects compared to conventional ropivacaine.

In rodent models, this nanocrystal formulation provided effective pain relief without causing local toxicity, suggesting it could be a safe and effective option for long-term postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction Between Ropivacaine and a Self-Assembling Peptide: A Nanoformulation for Long-Acting Analgesia. Peng, F., Liu, J., Zhang, Y., et al.[2022]

In a study of 310 patients undergoing major abdominal colorectal surgery, continuous wound infusion of ropivacaine provided minimal benefit compared to saline, showing no significant differences in pain management or recovery outcomes.

While there was a slight reduction in pain on movement on Day 1 for the ropivacaine group, this effect was not sustained beyond the first day, indicating that a multimodal approach to pain management remains the most effective strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous wound infusion of local anesthetic for the control of pain after elective abdominal colorectal surgery. Polglase, AL., McMurrick, PJ., Simpson, PJ., et al.[2018]

In a study of 24 patients across three age groups, it was found that older patients (aged 61 and above) had a significantly longer elimination half-life and decreased clearance of ropivacaine after epidural administration, indicating that age affects the drug's pharmacokinetics.

Despite these age-related differences in absorption and elimination, the study concluded that they are unlikely to increase the risk of systemic toxicity from a single epidural dose of ropivacaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of age on the systemic absorption and systemic disposition of ropivacaine after epidural administration. Simon, MJ., Veering, BT., Vletter, AA., et al.[2018]

A case report describes a patient who experienced withdrawal symptoms after a continuous epidural analgesia with ropivacaine was abruptly stopped, highlighting the potential for withdrawal effects from this local anesthetic.

The symptoms of agitation, tremors, tachycardia, and tachypnea resolved quickly after re-administering ropivacaine, suggesting that prolonged use may lead to physiological changes, such as upregulation of sodium channels, which could contribute to withdrawal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ropivacaine withdrawal syndrome: a case report]. Viderman, D., Portnyagin, I., la Fleur, P., et al.[2022]

Infusing ropivacaine at the port sites after laparoscopic cholecystectomy significantly reduced postoperative pain scores at 1 hour and at discharge compared to normal saline, indicating its efficacy in pain management.

Patients receiving ropivacaine also required less meperidine for pain relief and had shorter hospital stays, suggesting that this local anesthesia technique can enhance recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local anesthesia with ropivacaine for patients undergoing laparoscopic cholecystectomy. Liu, YY., Yeh, CN., Lee, HL., et al.[2022]

In a study of 38 patients undergoing spine stabilization surgery, continuous wound instillation of ropivacaine significantly reduced pain scores and the need for additional pain medication compared to standard IV morphine and ketorolac treatment.

The use of ropivacaine not only improved pain management but also resulted in less postoperative blood loss and a shorter hospital stay, with no observed toxic side effects, indicating its safety and efficacy for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Bianconi, M., Ferraro, L., Ricci, R., et al.[2022]

A case report of a 75-year-old woman showed that despite the general safety profile of ropivacaine, it can still cause serious side effects like convulsions immediately after epidural administration, highlighting the need for caution in elderly patients.

The patient experienced a generalized tonic-clonic convulsion but recovered well after treatment, indicating that while ropivacaine is associated with good cardiovascular stability, there remains a risk of inadvertent intravascular injection during epidural procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine-induced convulsion immediately after epidural administration--a case report. Cherng, CH., Wong, CS., Ho, ST.[2018]

In a study involving continuous infusion of ropivacaine after colon cancer surgery, the maximum unbound ropivacaine concentration was significantly below the toxicity threshold, indicating a strong safety profile for this pain management approach.

The infusion of ropivacaine for 96 hours was found to be a safe alternative to standard opioid analgesia, potentially reducing opioid-related side effects and improving patient recovery, while also suggesting that higher doses could be tested for better pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 96-hour incision-site continuous infusion of ropivacaine for postoperative analgesia after bowel cancer resection. Corso, OH., Morris, RG., Hewett, PJ., et al.[2018]

Ropivacaine is generally considered safer than bupivacaine due to its lower systemic toxicity, but this case highlights that it can still cause serious side effects, such as seizures.

In a reported case, a patient experienced a seizure after receiving 120 mg of ropivacaine intravenously, indicating that while the risk is lower, systemic toxicity can still occur with ropivacaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine-induced seizure after extradural anaesthesia. Abouleish, EI., Elias, M., Nelson, C.[2019]

Continuous wound infusion of ropivacaine significantly reduced postoperative pain scores and opioid consumption in 60 patients after open hepatectomy, leading to better pain management.

Patients receiving ropivacaine also experienced faster bowel recovery and shorter hospital stays, with no reported surgical wound infections, indicating that this method is both safe and effective for enhancing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of postoperative continuous wound infiltration with local anesthesia after open hepatectomy]. Yu, H., Li, ZY., Yu, X.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06574269

A Study on TLC590 for Managing Postsurgical Pain This Phase 2 open-label trial investigates the pharmacokinetics (PK), pharmacodynamics, and safety profile of TLC590 across various surgical procedures.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03838133

A Study to Evaluate Safety, PK, Efficacy of TLC590 for ... The primary objective of this study is to evaluate the analgesic efficacy of TLC590 for post-surgical pain management in subjects following bunionectomy.

3. tlcbio.com tlcbio.com/en/pipeline/TLC590

TLC590 - Pipeline Fast, immediate onset of pain relief; Extended pain relief of 72 hours and beyond; Less cardiovascular and central nervous system toxicity than bupivacaine ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12326373/

Liposomal bupivacaine vs. Ropivacaine for wound ... This study focuses on the long-term pain outcome to assess the efficacy of liposomal bupivacaine wound infiltration in preventing chronic pain ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1526590020300584

Injectable PLGA-Coated Ropivacaine Produces A Long ... The present study demonstrated that injectable PLGA-coated RVC produced prolonged analgesic effects on postsurgical pain and neuropathic pain after single-dose ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07222748

A Phase 3 Study on TLC590 for Managing Postsurgical ... This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via ...