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 range18 Years – 80 Years
SexALL
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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…
What they're measuring
1
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)