Postoperative Pain Therapy With Hydromorphone TCI-PCA vs. Morphine PCA

Study Overview
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Brief Summary
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Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery

Official Title
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Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) With Morphine After Elective Cardiac Surgery

Conditions
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Acute Postoperative Pain

Intervention / Treatment
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* Drug: Hydromorphone
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay Exclusion Criteria: Administration of other analgesics or sedatives, if not administered in stable dosages for at least 14 days or if not used for premedication and surgery Administration of hydromorphone or morphine in the period between screening and surgery Severe hepatic or renal impairment in medical history BMI>= 35 ASA>= 4

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TCI-PCA<br> | Drug: Hydromorphone<br>* Hydromorphone is given intravenously by TCI-PCA. The TCI-PCA system steer the hydromorphone infusion pump to achieve plasma and effect-site concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma and effect-site concentration range, lockout times and infusion speed.<br>|
| Active Comparator: PCA<br> | Drug: Morphine<br>* Morphine is given intravenously by PCA. The PCA pump administers a predefined bolus dose on patient request considering the predefined lockout time and infusion speed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Score | Comparison of pain analgetic efficacy between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage | up to 17 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Observer's Assessment of Alertness/Sedation Scale | Comparison of opioid induced sedation level between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage | up to 17 hours after extubation | 
| Postoperative Nausea and Vomiting | Comparison of opioid associated nausea and vomiting between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage | day of surgery | 
| Respiratory Frequency | Comparison of opioid induced respiratory depression between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage | up to 17 hours after extubation |