To determine whether the intravenous coadministration of morphine and oxycodone has fewer opioid related adverse effects (AEs) than morphine alone at doses that result in effective and equi-analgesic pain relief for acute post operative pain, and to determine the doses of morphine and oxycodone co-administered versus morphine required to achieve effective pain relief. MedDRA version: 9.1 Level: LLT Classification code 10036276 Term: Postoperative analgesia MedDRA version: 9.1 Level: LLT Classi
Conditions
Interventions
Trade Name: Oxygesic Injekt 10mg/1ml
Product Name: Oxygesic injekt 10mg/1 ml
Pharmaceutical Form: Injection*
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
CAS Number: 124903
Concentration unit: % (W/V)
Sponsors
University of Witten/Herdecke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To qualify for enrollment in this study, the patient must: -have voluntarily provided written informed consent and HIPAA authorization prior to any study-related procedures are performed; -be male or female, at least 18 years of age, at the time of enrollment; -have undergone a primary unilateral total hip replacement performed under standardized general, spinal, or epidural anesthesia; -be scored I-III on the American Society of Anesthesiologists (ASA) physical status classification system; -have developed moderate or severe pain on a 11-point NPRS (> 4) scale within 6 hours post end of surgery (time of last stitch)on the day of surgery. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient will be excluded from enrollment in this study if the patient: -has a history of acute or severe asthma, chronic pulmonary disease, renal disease, Addison’s disease (chronic adrenal insufficiency), head injury, elevated intracranial pressure, convulsive states, congestive heart failure current cardiac arrhythmia, current transient cerebral ischemic attacks, current uncontrolled unstable co-existent systemic disease, other medical condition, laboratory abnormality, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study; -has allergy, hypersensitivity, or contraindications to opioids or acetaminophen; -has positive HIV serology or signs of HIV infection or AIDs; -has positive HBsAg or HCV antibody; -has undergone any other surgical procedure, either related or unrelated, during the same surgery session; -has a total hip replacement procedure time greater than 6 hours; -has a history of drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements; -has current evidence of alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Treatment Period – Part 1 1. The number (%) of patients in the morphine/oxycodone and morphine treatment groups who achieve the target pain score defined as mild or no pain on the 4 point Likert scale or 2 or less on the 11 point NPRS (NCA responders). 2. The change in pain scores from baseline, as well as the percentage of patients categorized as Responders for the following time intervals: during the NCA period just prior to administration of study medication at Time 0 (Baseline) to 30 min and to 60 minutes and to the end of the NCA period (Part 1), and every 4 hours during the PCA (Part 2) period until hour 48 or time or early termination. Responders are defined as subjects with a decrease from baseline in NPRS score of at least 30%. Responder analysis will also be evaluated for decrease from baseline in NPRS score or 10%, 20%. 40%,and 50%. 3. The amount of study medication (measured in “mg”) required by patients in each treatment group for the Part 1 and Part 2 time intervals specific in item 2, above. 4. Patient Global Assessment of Effectiveness at approximately 8AM on the day following surgery (Day 2) and at hour 48 or at time of early termination. 5. The amount of supplemental analgesia (measured in “mg”) required by patients in each treatment group on Day 1 (for each time interval and overall). 6. Time to first dose of PCA medication from the end of NCA, for NCA responders in each treatment group. Treatment Period – Part 2 1. SPID4H scores for the following time intervals: from the start of Part 2 on Day 1 to the end of the 48 hour evaluation period 2. Percent Reduction Responders from the start of Part 2 on Day 1 to the 8 AM on Day 2 and from 8 AM on Day 2 to Hour 48. Responders are defined as subjects with a decrease from baseline in NPRS score of at least 30%.. Responder analysis will also be evaluated for decrease from baseline in NPRS score or 10%, 205. 40%,and 50%. 3. The amount of study medication (measured | — |
Countries
Germany
Outcome results
None listed