Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

Avenue Therapeutics

Status and phase

Completed

Phase 3

Conditions

Pain Management

Treatments

Drug: Tramadol

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03290378

AVE-901-102

Details and patient eligibility

About

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

Full description

(Non-clinical summary)

Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioidlike effects. Tramadol is extensively metabolized following administration, which results in a number of enantiomeric metabolites that display different opioid-receptor binding properties, and monoaminergic reuptake inhibition.

Enrollment

409 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase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