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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This is a double-blind (neither the patient nor the study doctor knows the name of the
      assigned study drug during the study), randomized (study drug selected by chance like
      flipping a coin), active-comparator (patient will get active drug and there is no inactive
      drug), outpatient study to evaluate efficacy and how well a patient tolerates multiple doses
      of tapentadol immediate release (IR) versus oxycodone IR for short-term moderate to severe
      post-operative pain after arthroscopic (a surgical technique whereby a doctor inserts a
      tube-like instrument into a joint to visually inspect and repair tissues) shoulder surgery.
      About 370 patients will be enrolled to either receive tapentadol IR or oxycodone IR until
      approximately 150 patients in each treatment group are enrolled. After obtaining informed
      consent, patients will have screening visit procedures to determine study eligibility. Visit
      1 (screening) may begin up to 21 days prior to surgery. Pre-operative assessments (e.g.,
      physical examinations, clinical laboratory assessments) will be conducted as part of routine
      procedures. Patients will have a urine drug test and women who are able to have children will
      have a urine pregnancy test performed as part of screening prior to the study. Height and
      weight will be taken and a sleep questionnaire will also be completed at screening. Study
      staff will conduct pre-operative teaching regarding post-operative pain including: the pain
      intensity assessment for the study (11-point numeric rating scale where 0=no pain and 10=pain
      as bad as you can imagine); descriptions of mild, moderate and severe pain; instructions for
      dosing with study medication; and completing the study diary. Eligible patients will be
      post-operative men and women who have undergone elective outpatient arthroscopic shoulder
      surgery. Patients must have received a regional interscalene (within the scalene muscles)
      nerve block as the primary anesthetic (numbing medication) during the procedure and do not
      require intravenous (through a vein) patient-controlled analgesia post-operatively. Patients
      who are expected to have moderate to severe acute post-operative pain from shoulder surgery
      and who are appropriate candidates for outpatient pain management with an oral opioid
      (narcotic) pain medication will be eligible. In addition, appropriate patients are expected
      to require oral opioid pain medication post-operatively. Patients who continue to meet all
      study criteria post-operatively will be assigned to a study drug group prior to PACU
      discharge (PACU is considered Visit 2) and will be sent home with study medication. All
      patients will be prescribed a standard regimen of cold pack application to the surgical
      shoulder. Patients will be instructed to take the first dose of study medication as their
      first oral pain medication when they have at least "moderate" pain (prior to discharge or at
      home). Patients will be reminded about instructions on post-operative pain that were
      discussed during the pre-operative screening visit. Patients will also be instructed to
      complete a diary assessment of their current pain intensity before taking the first dose of
      study medication. Day 1 will be the calendar day when the patient takes the first dose of
      study medication. Starting on Day 1, patients will be instructed to complete assessments in
      paper diaries each morning and evening related to pain intensity, pain relief, and
      occurrences of vomiting. All patients will be contacted by telephone by a member of the study
      staff on the day following surgery. The staff will verify that the first dose of study
      medication was taken and the baseline pain intensity assessment was recorded. All patients
      will receive a second telephone call from the study staff on Day 3. During this telephone
      call, site personnel will inquire about the patient's overall status and will reinforce diary
      compliance. If the study staff determines it is necessary, the patient will be required to
      return to the study site for an unscheduled visit. Patients may take up to 2 pills (any form)
      of acetaminophen for pain other than post-operative shoulder pain (e.g., headache, back pain)
      once per day only for up to a total of 2 days during the study. Patients who take up to 325
      mg/day aspirin as prevention for a heart condition will be permitted to enter the study and
      continue on study medication provided they are on a stable dose for at least 1 month prior to
      study entry and plan to continue the same dose during the study. Patients who complete the
      study will return to the study site for a final visit (Visit 3) on Day 7. Patients who
      discontinue early for any reason (i.e., lack of efficacy, adverse events, patient's choice)
      should contact the study staff before taking supplemental pain medication and schedule
      his/her final visit. Patients will complete a final assessment of pain intensity and pain
      relief. In addition, all patients will complete a sleep questionnaire, a Patient Global
      Impression of Change and an assessment of satisfaction with treatment. The study doctor will
      complete a Clinician Global Impression of Change and will record any medical resource
      utilization noted in the office charts (e.g., unplanned calls from the subject, unscheduled
      office visits, emergency room visits). Vital signs will be obtained and study medication will
      be collected and counted. Patients will have adverse events assessed and any changes in
      concomitant medications (other medications taken at the same time as the study medication)
      recorded. All patients will have post-study medication prescribed at the study doctor's
      discretion. A patient may elect to take supplemental pain medication to treat their
      post-operative shoulder pain at any time during the study; however, patients who take
      supplemental pain medication will be considered discontinued from the study. Patients will be
      assigned by chance equally (1:1) in a blinded (neither the patient or study doctor knows)
      fashion to get tapentadol immediate release (IR) 50 or 100 mg vs oxycodone IR 5 or 10 mg,
      every 4-6 hours as needed. Treatment is up to 7 days starting on Day 1 with one capsule of
      study medication. A "re-dose" is permitted and may be administered as soon as one hour after
      the first dose only. For subsequent doses, patients may take one or two capsules every 4 to 6
      hours as needed.
    

Intervention name(s): Tapentadol IR; Oxycodone IR
Intervention type(s): Drug; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesia; postoperative pain; opioid; rotator cuff repair; labral tear repair; Bankart procedure; oxycodone; tapentadol; arthroscopic shoulder surgery