A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a 300-mg Dose of the INL-001 (Bupivacaine Hydrochloride) Implant in Patients Undergoing Abdominoplasty

INN-CB-024

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.

2021-04-29

2021-10-27

2021-10-27

Completed

Early phase I

366

Inclusion Criteria * 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. Exclusion Criteria * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Matching placebo', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 366, 'type': 'ACTUAL'}}

2022-11-21