Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

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• •The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase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.