Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain, Postoperative, Abdominoplasty

In brief

This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia.

Key facts

Study ID

NCT04785625

Run by

Innocoll

People needed

366

Starts

2021-04-29

Expected to finish

2021-10-27

Last updated by the study team

2022-11-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a body mass index of 18-35 kg/m2.
• Must qualify for a planned (nonemergency) abdominoplasty with rectus sheath plication, with an incision that does not extend beyond the umbilicus, to be performed using standard surgical technique under general anesthesia.
• Has the ability and willingness to comply with all study procedures including being domiciled for at least 72 hours after surgery.
• Is willing to use opioid analgesia, if needed.

You may not qualify if…

• Has a known hypersensitivity to amide-type local anesthetics, fentanyl, morphine, oxycodone, acetaminophen, NSAIDs, or bovine products.
• Is scheduled for other significant concurrent surgical procedures (eg, gastrointestinal resection or additional cosmetic procedures concurrent with abdominoplasty).
• Has used an opioid analgesic on an extended daily basis (≥5 mg oral morphine equivalents per day for 3 or more days a week) within 4 weeks before surgery and/or chronically uses pain medication.
• Has any chronic painful condition (eg, fibromyalgia), as determined by the investigator, that may confound the assessment of pain associated with the abdominoplasty procedure

Where it is running

• Lotus Clinical Research — Pasadena, California, United States
• Midwest Clinical Research — Dayton, Ohio, United States
• HD Research — Bellaire, Texas, United States
• Endeavor Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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