- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01816581
Oral Oxycodone After Major Cardiac Surgery
Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain After Major Cardiac Surgery
Postoperative pain and analgesic treatment still remains a challenge in daily perioperative medicine. Skin incisions, intraoperative tissue retraction and -dissection, intravasal cannulations and drainages, sternotomy and pericardiotomy are the most important reasons for postoperative pain. Poorly controlled pain can contribute directly or indirectly to postoperative complications, such as myocardial ischemia, pulmonary dysfunction like hypoventilation, pneumonia and atelectasis, a delayed return of gastrointestinal function and decreased mobility. In addition, prolonged acute pain also results in chronic pain.
Opioids are internationally recognized as the golden standard in the treatment of acute postoperative pain. On one side, the high potency of opioids in pain relief is clearly undisputed, but on the other hand, the administration of opioids is associated with nausea, vomiting, sedation and with the development of bowel dysfunction, which encompasses symptoms including bloating, abdominal spasm, cramps and constipation. Opioid-induced constipation is a frequently reported adverse effect and sometimes requires discontinuation of therapy, which results in analgesic under-treatment, severely impairing quality of life. However, there are many different regimes for the treatment of postoperative pain using opioids. Patient-controlled analgesia (PCA) using morphine is widely used, but requires trained staff and expensive equipment. Once patients are able to tolerate oral medications, the oral route is preferred postoperatively because it is more convenient, noninvasive and less expensive.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Vienna, Austria, 1090
- Medical University Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age from 18 to 90 years
- ASA physical status 1-3
- Elective major cardiac surgery requiring sternotomy
- Oral and written consent
- Postoperative extubation within four hours after arrival at the ICU
- Cognitive ability in the use of the PCA pump and the VAS
Exclusion Criteria:
- Chronic use of opioids in the last three months
- Chronic use of tranquilizer or pain medications
- Hypersensitivity against opioids
- Use of monoamine oxidase inhibitors in the last two weeks before surgery
- Alcohol or drug abuse
- Renal dysfunction (GFR < 30 or necessity of dialysis)
- Liver Dysfunction defined as Child-Pugh-Score 7-15
- Ejection fraction (EF< 40%)
- Malabsorption syndrome
- Neurologic or cognitive dysfunction
- Pregnancy
- Participation in another clinical trial
- Severe respiratory depression with hypoxia and/or hypercapnia
- Severe chronic obstructive pulmonary disease
- Severe bronchial asthma
- Non-opioid induced paralytic ileus
- Risk of seizures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Targin/OxyNorm
Patients randomized to this study arm will receive Targin as basis pain medication and additional OxyNorm (Oxycodone), if requested by the patients.
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Other Names:
Other Names:
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Active Comparator: PCA
Patients randomized to this group will receive a PCA pump with morphine.
The basic rate is 0.3 mg/h.
Patients will be allowed to administer 1 mg each five minutes after a vesting period of five minutes, if subjectively needed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total opioid dosage in terms of so-called morphine equivalents
Time Frame: 3 days
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total administrated opioid dosage during 3 days after surgery
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3 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS pain score
Time Frame: 3 days
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Pain Scores on the Visual Analog Scale (0-100)
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3 days
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level of sedation
Time Frame: 3 days
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Level of Sedation using the Ramsey Sedation Score.
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3 days
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rate of spontaneous breathing
Time Frame: 3 days
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spontaneous breathing rate per minute
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3 days
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possible side effects
Time Frame: 3 days
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open documentation of any side effects like dizziness, vomiting, allergic reaction
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3 days
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in hospital stay
Time Frame: 1 month
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1 month
|
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ICU stay
Time Frame: 1 month
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1 month
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1043/2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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