An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a bupivacaine implant to manage pain in patients after soft-tissue surgeries. The implant releases medication at the surgery site to numb the area and reduce pain. It aims to help patients who undergo surgeries like hernia repair and tummy tucks. Liposomal bupivacaine has been shown to be effective in managing postoperative pain in various surgeries, including abdominal and plastic surgeries.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been using opioid painkillers regularly in the last four weeks.
What safety data exists for the INL-001 (bupivacaine hydrochloride) implant?
The INL-001 implant has been studied for safety in surgeries like hernia repair and abdominoplasty. It is designed to provide extended pain relief and reduce the risk of accidental injection, which can happen with traditional bupivacaine use. Studies have shown it to be generally safe for use in humans.12345
How does the drug INL-001 differ from other treatments for postsurgical pain?
INL-001 is a bupivacaine HCl collagen-matrix implant that provides extended pain relief directly at the surgical site, unlike traditional bupivacaine injections that offer only short-lived pain relief and carry a risk of accidental injection into the bloodstream. This implant avoids these risks and offers prolonged analgesia, making it a unique option for managing postsurgical pain.12467
What data supports the effectiveness of the drug INL-001 (bupivacaine hydrochloride) implant?
Who Is on the Research Team?
Anne Arriaga
Principal Investigator
Lotus Clinical Research
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Inpatient Treatment
Participants undergo surgery and receive the INL-001 implant under general anesthesia, with assessments for safety and efficacy conducted during the inpatient stay.
Outpatient Follow-up
Participants are monitored for safety and effectiveness after treatment, with scheduled assessments at multiple time points.
What Are the Treatments Tested in This Trial?
Interventions
- INL-001 (bupivacaine hydrochloride) implant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Innocoll
Lead Sponsor