Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute … (NCT00814580) | Clinical Trial Compass
CompletedPhase 3
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
382 participantsStarted 2008-12
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treatme…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)