Pain Therapy After Elective Cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine generation of a target controlled infusion model for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned open heart surgery, during which the strong analgesic, sufentanil, was used.

Official Title
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Pharmacokinetic-pharmacodynamic Modeling of the Postoperative Pain Sensation During Patient-controlled Analgesia With Target-controlled Infusion of Hydromorphone, Taking Into Account the Interaction With Intraoperatively Administered Sufentanil for Elective Cardiac Surgery

Conditions
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Pain

Intervention / Treatment
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* Drug: Sufentanil, Hydromorphone
* Drug: Sufentanil, Hydromorphone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent, Ability to understand the nature of patient-controlled analgesia and other study-specific procedures, Elective cardiac surgery with thoracotomy and subsequent stay in the intensive care unit Exclusion Criteria: Use of MAO inhibitors in the last 14 days, Chronic alcoholism or drug addiction in medical history, Severe obstructive or restrictive pulmonal disorders in medical history, Severe hepatic and renal disorders in medical history, Hypothyroidism, pancreatitis in medical history, ASA IV, Pregnant or nursing females

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 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: Sufentanil Group 1<br>Sufentanil Low Titration | Drug: Sufentanil, Hydromorphone<br>* Intraoperatively: Target controlled infusion with 0.4 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone<br>|
| Active Comparator: Sufentanil Group 2<br>Sufentanil High Titration | Drug: Sufentanil, Hydromorphone<br>* Intraoperatively: Target controlled infusion with 0.8 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of sufentanil and hydromorphone | 28 blood samples are taken during the study period of 48 hours postoperatively for characterizing the pharmacokinetics | 48 hours | 
| Numerical Rating Scale for Clinical Pain | 11 assessments of patient's pain sensation using Numerical Rating Scale for Clinical Pain during patient-controlled analgesia with target-controlled infusion of hydromorphone 8 hours after extubation for characterizing the analgesic effect | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of hydromorphone | Cumulative dose of hydromorphone for patient-controlled analgesia with target-controlled infusion of hydromorphone for characterizing the analgesic requirement | 8 hours | 
| Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale | 11 assessments of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale during patient-controlled analgesia with target-controlled infusion of hydromorphone 8 hours after extubation for characterizing the sedation level | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetic-pharmacodynamic modeling, Patient-controlled analgesia, Target-controlled infusion, Hydromorphone, Sufentanil, after thoracotomy, cardiac surgery