Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: XaraColl; Placebo
Intervention description: Surgical implantation of 3 bupivacaine collagen implants; Plain collagen implant (vehicle)
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 319.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: post operative pain; hernioplasty; bupivacaine

Summary:

      This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled
      efficacy and safety study of postoperative pain in adults who are scheduled for unilateral
      inguinal hernioplasty via open laparotomy (tension-free technique).

      Patients will assess their postoperative pain intensity (PI) using an 11-point numerical
      rating scale (NRS) from 0 hour through 72 hours postoperatively.

      The expected maximum study duration for each patient will be up to 60 days, including a
      maximum 30-day screening period, the day of surgery and implantation, and a 30-day post
      implantation period including treatment and follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a planned (non-emergent) unilateral inguinal hernioplasty (open laparotomy,
             tension-free technique) to be performed according to standard surgical technique under
             general anesthesia. Repair of multiple hernias through a single incision is permitted
             provided only a single mesh will be used.

          -  If female, is nonpregnant and nonlactating.

          -  If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1
             year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or
             hysterectomy]) or practicing 1 of the protocol specified medically-acceptable methods
             of birth control and agrees to continue with the regimen throughout the duration of
             the study:

          -  Has the ability and willingness to comply with the study procedures and use of the
             eDiary.

          -  Is willing to use only permitted medications throughout the study.

          -  Is willing to use opioid analgesia.

          -  Must be able to fluently speak and understand either English or Spanish and be able to
             provide meaningful written informed consent for the study.

        Exclusion Criteria:

          -  Has a known hypersensitivity to amide local anesthetics, morphine, acetaminophen or
             bovine products.

          -  Is scheduled for bilateral inguinal hernioplasty or other significant concurrent
             surgical procedures per investigator discretion.

          -  Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to
             undergo another laparotomy procedure within 30 days postoperatively.

          -  Has used any analgesic other than acetaminophen within 24 hours of surgery.
             Acetaminophen may be used on the day of surgery but is subject to preoperative
             restrictions for oral intake.

          -  Has used aspirin or aspirin-containing products within 7 days of surgery. Aspirin at a
             dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the patient has been on
             a stable dose regimen for ≥ 30 days before Screening.

          -  Has used systemic steroids, anticonvulsants, antiepileptics, antidepressants for the
             management of chronic pain, or monoamine oxidase inhibitors on a regular basis within
             10 days of surgery.

          -  Has used any opioid analgesic for an extended daily basis (30 - 60 mg oral morphine
             equivalent per day for 3 or more days a week) within 4 weeks before surgery. Patients
             who, in the investigator's opinion, may be developing opioid tolerance are also
             excluded.

          -  Has any chronic painful condition (eg, fibromyalgia) or routinely uses pain medication
             other than acetaminophen (including nonsteroidal anti-inflammatory drugs [NSAIDs])
             that, in the opinion of the investigator, may confound the assessment of pain
             associated with the hernioplasty.

          -  Has a physical or mental condition that, in the opinion of the investigator, may
             confound the assessment of postoperative pain after hernioplasty.

          -  Shows evidence of tolerance or physical dependency on opioid analgesics or
             sedative-hypnotic medications.

          -  Has a urine drug screen that tests positive for drugs of abuse or misuse, including
             cannabinoids.

          -  Has liver function test results greater than 3x the upper limit of normal or a history
             of cirrhosis.

          -  Has any clinically significant unstable cardiac disease (eg, uncontrolled
             hypertension, clinically significant arrhythmia at baseline, or an implantable
             cardioverter-defibrillator [ICD])

          -  Has any clinically significant unstable neurological, immunological, renal, or
             hematological disease (eg, uncontrolled diabetes or significantly abnormal laboratory
             findings), or any other condition that, in the opinion of the investigator, could
             compromise the patient's welfare, ability to communicate with the study staff or
             otherwise contraindicate study participation.

          -  Has an open workman's compensation claim.

          -  Has participated in a clinical trial (investigational or marketed product) within 30
             days of surgery.