An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries
Condition: Pain, Postoperative; Hernia, Ventral; Abdominoplasty; Hysterectomy; Colectomy; Reduction Mammoplasty
MeSH terms: Hernia; Pain, Postoperative; Hernia, Ventral
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of
      pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients
      following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open
      abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.
    

Detailed description: 
      This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of
      pharmacokinetics study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients
      following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open
      abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty. After a
      screening period, eligible patients will undergo study surgery under general anesthesia and
      have INL-001 implanted intraoperatively. Efficacy is also an exploratory measure in this
      study.

      The study includes a screening period, an inpatient period (preoperative, intraoperative,
      postoperative) of approximately 5 days, and an outpatient follow-up period (up to 30 days
      after treatment). Posttreatment safety and/or efficacy assessments will be made throughout
      the study and as specifically scheduled through 96 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, patients will be discharged approximately 96 hours
      posttreatment (inpatient day 5).

      During the screening period, all patients will undergo eligibility and other screening and
      safety assessments. In addition, the investigator will administer the Pain Catastrophizing
      Scale (screening only) as an exploratory measure and the 15-item Quality of Recovery (QoR-15)
      questionnaire (baseline).

      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.

      Blood samples for pharmacokinetic assessments will be collected from patients at multiple
      time points for the measurement of concentrations of bupivacaine in plasma.

      After surgery, patient reports of pain intensity using an 11-point numeric pain rating scale
      (NPRS) will be recorded at multiple time points through 96 hours posttreatment. Patients will
      be permitted rescue medication (oral and/or intravenous) to manage breakthrough pain when it
      occurs. The QoR-15 questionnaire and Patient Global Assessment (for pain control) will be
      administered on an inpatient basis and on day 7. The Opioid Related Symptom Distress Scale
      will be administered on an inpatient basis.
    

Intervention name(s): INL-001 (bupivacaine hydrochloride) implant
Intervention type(s): Combination Product
Intervention description(s): INL-001 (bupivacaine hydrochloride) implant
Other intervention name(s): XARACOLL (bupivacaine hydrochloride) Implant
Intervention MeSH terms: Bupivacaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Analgesia; Postoperative; Hernia; Abdominoplasty; Tummy tuck; Hysterectomy; Colectomy; Bupivacaine; Postsurgical; Implant; Safety; Efficacy; Pharmacokinetic; Opioid; Nonopioid; Post-operative; Post-surgical; Surgery; Soft tissue; Open-label; Phase 3; Local anesthetic