Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Tapentadol IR; Oxycodone IR
Intervention description: First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1, if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed; First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1, if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed
Intervention MeSH terms: Oxycodone; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: analgesia; postoperative pain; opioid; rotator cuff repair; labral tear repair; Bankart procedure; oxycodone; tapentadol; arthroscopic shoulder surgery

Summary:

      The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone
      IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy on the basis of medical history and vital signs and meeting the American
             Society of Anesthesiology (ASA) physical status I, II, or III

          -  completed screening procedures and have undergone one of the following elective
             outpatient arthroscopic surgical procedures: rotator cuff repair, labral tear repair,
             Bankart repair

          -  an arthroscopic mini-open rotator cuff repair

          -  (an arthroscopic distal clavicle resection performed in conjunction with a rotator
             cuff, labral tear or Bankart repair is also permitted)

          -  received anesthesia administered to the shoulder by interscalene nerve block

          -  receive study medication as the first oral analgesic medication following the
             orthopedic surgical procedure and expected to have moderate to severe pain requiring
             oral opioids for at least 3 days after surgery.

        Exclusion Criteria:

          -  Patients whose post-operative pain would require non opioid analgesia as standard of
             care

          -  received a non-allowed procedure

          -  received intraoperative or post-operative anesthesia and/or analgesic medications
             which are expected to provide post-operative analgesia for >24 hours after discharge
             from the PACU (recovery room)

          -  received intraoperatively >200 mg fentanyl or the morphine equivalent of another
             opioid (for the total procedure) or potent inhaled anesthesia (e.g., sevoflurane,
             isoflurane)

          -  received IV PCA analgesia (intravenous pump the patient controls) in the PACU or a
             PACU stay >8 hours

          -  expected to require inpatient treatment in a hospital or rehabilitation unit post
             operatively

          -  anticipate any surgical procedure(s) within 7 days after the initial shoulder surgery

          -  have significant nausea and/or vomiting at the time of randomization (patients may
             receive an anti-emetic prior to or during surgery)

          -  received any of the following: long-acting or controlled-release opioids within
             1-month prior to randomization

          -  immediate release CII opioid formulations (e.g., Opana IR, Percocet, Percodan,
             oxycodone IR, Dilaudid) for >5 days total within 1 month before, and within 24 hours
             of, randomization

          -  intra-articular (within a joint) or systemic steroids (except inhalers and topical
             steroids), within 1 month before randomization (exception, patients on a stable dose
             of chronic steroids for a minimum of 3 months, for a condition other than the shoulder
             pain)

          -  use of non-steroidal anti-inflammatory drugs (NSAIDs) within 24-hours of randomization

          -  have taken any CIII opioid formulation (e.g., Tylenol with Codeine) >3 days/week in
             the 1-month prior to randomization

          -  treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic
             antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitors
             (SNRIs) within 2 weeks before randomization

          -  positive urine drug screen (cocaine, methadone, amphetamines, cannabinoids, opiates,
             benzodiazepines, barbiturates, and oxycodone)

          -  have an active systemic or local infection

          -  significant co-existing autoimmune inflammatory conditions

          -  history of seizure disorder or epilepsy

          -  presence of any of the following: mild or moderate traumatic brain injury, stroke,
             transient ischemic attack, or brain neoplasm within 1 year of screening

          -  severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours
             duration, or post-traumatic amnesia of more than 24 hours duration within 15 years of
             screening

          -  known history of alcohol or drug abuse in the study doctor's judgment based on medical
             history

          -  known or suspected to be opioid tolerant or dependent

          -  known history of laboratory values reflecting severe kidney disease, known history of
             moderately or severely impaired liver function

          -  history of allergy to, or hypersensitivity to tapentadol, oxycodone, or other
             components of the medication

          -  history (within the past 6 months) of a major psychiatric disorder

          -  history of suicidal ideation or suicidal attempts within the past 2 years

          -  currently involved in litigation regarding their shoulder injury, have a disability
             claim or patients who are receiving Worker's Compensation due to their shoulder injury
             or are being evaluated to receive disability or Worker's Compensation