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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Collaborator: Grünenthal GmbH
• Treatments: Oxycodone; Tapentadol

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