Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
Condition: Pain Management
MeSH terms: Pain, Postoperative
Intervention: Tramadol; Placebo
Intervention description: IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
Intervention MeSH terms: Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 409.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing
      postoperative pain following a bunionectomy
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  The patient is male or female 18-75 years of age undergoing unilateral first
             metatarsal bunionectomy surgery

          -  Willing to give consent and able to understand the study procedures

          -  Female patients must be of non-childbearing potential or be practicing a highly
             effective contraception

          -  The patient must be willing to be housed in a healthcare facility and able to receive
             parenteral analgesia for at least 72 hours after surgery.

          -  The patient meets definition of American Society of Anesthesiologists (ASA) Physical
             Class 1, or 2.

        Exclusion Criteria:

          -  Patient is not expected to receive a continuous infusion nerve block as described in
             the Post-Op anesthetic procedures protocol

          -  Patient is undergoing bilateral or revision bunionectomy surgery

          -  The patient has allergy or hypersensitivity (or is intolerant) to opioids or tramadol
             The patient has known physical dependence on opioids

          -  The patient has taken other prior/concurrent chronic medications that have not been at
             a stable dose for at least 2 weeks prior to screening

          -  The patient is taking herbal or dietary supplements or medications that are moderate
             or strong inhibitors of CYP2D6 or CYP3A4 or inducers of CYP3A4

          -  The patient has taken monoamine oxidase (MAO) inhibitors, trazodone, or
             cyclobenzaprine within 14 days prior to surgery

          -  The patient cannot be withdrawn from medications (at least 7 days prior to surgery)
             that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or
             which increase serotonergic tone (e.g. selective serotonin reuptake inhibitors
             (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic
             antidepressants, triptans).

          -  The patient has a history of epilepsy, or is known to be susceptible to seizures

          -  The patient has a history of Long QT Syndrome or a relative with this condition

          -  The patient has expressed suicidal ideation or is considered to be at risk of suicide.

          -  The patient is morbidly obese (body mass index [BMI] ≥ 40 kg/m2) or has documented
             sleep apnea requiring pharmacological or device intervention.

          -  Clinically significant abnormalities in the judgement of the Investigator

          -  The patient was administered an investigational product within 30 days prior to
             Screening.

          -  The patient has previously participated in a clinical study with AVE-901.