Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty
Condition: Pain, Postoperative; Abdominoplasty
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
      Patients will undergo abdominoplasty and have INL-001 or placebo implanted intraoperatively.

      The study includes a screening period, an inpatient period (preoperative, intraoperative,
      immediately postoperative) of approximately 4 days and an outpatient follow-up period (up to
      30 days after treatment). Efficacy assessments will be made through 72 hours after treatment
      (after implant placement). Posttreatment safety assessments will be made throughout the study
      after the informed consent form is signed, and as specifically scheduled through 72 hours
      posttreatment, on day 7 (telephone), on day 15 (clinic visit), and on day 30 (clinic visit).
      Unless the investigator determines further hospitalization is necessary, the patient will be
      discharged on the day occurring 72 hours after surgery Inpatient day 4).

      During the screening period, all patients will undergo eligibility and other screening and
      safety assessments. On the day of surgery, patient eligibility will be reconfirmed before the
      start of surgery, patients will be randomly assigned to treatment, and adverse events and
      prior/concomitant medications will be reviewed. Patients will undergo an abdominoplasty
      conducted under general anesthesia.

      Adverse event and concomitant medication information, including use of rescue pain
      medication, will be collected throughout the study (inpatient and outpatient). Surgical wound
      healing/grading assessments and assessment for signs and symptoms potentially indicative of
      systemic bupivacaine toxicity will be made.

      After surgery, patient reports of pain intensity using an 11-point numeric pain rating scale
      (NPRS) will be recorded at multiple time points through 72 hours posttreatment. Patients will
      be permitted rescue medication (oral and/or intravenous) to manage breakthrough pain when it
      occurs.
    

Intervention name(s): Bupivacaine Hydrochloride; Placebo collagen-matrix implant
Intervention type(s): Combination Product; Combination Product
Intervention description(s): INL-001 (bupivacaine hydrochloride) implant; Placebo collagen-matrix implant
Other intervention name(s): XARACOLL (bupivacaine hydrochloride) Implant
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Analgesia; Postoperative; Abdominoplasty; Bupivacaine; Implant; Postsurgical; Safety; Opioid; Tummy tuck; Efficacy; Post-operative; Post-surgical; Surgery; Placebo; Randomized; Double-blind; Phase 3; Nonopioid; Local anesthetic