Oral Oxycodone After Major Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain After Major Cardiac Surgery

Conditions
-----------------
Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: Targin
* Drug: Oxynorm
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Targin/OxyNorm<br>Patients randomized to this study arm will receive Targin as basis pain medication and additional OxyNorm (Oxycodone), if requested by the patients. | Drug: Targin<br> <br> * Other names: Oxycodonhydrochlorid and naloxone hydrochloride dihydrate;Drug: Oxynorm<br> <br> * Other names: oral medication consisting of Oxycodonhydrochlorid;|
| Active Comparator: PCA<br>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. | Drug: Morphine<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total opioid dosage in terms of so-called morphine equivalents | total administrated opioid dosage during 3 days after surgery | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score | Pain Scores on the Visual Analog Scale (0-100) | 3 days | 
| level of sedation | Level of Sedation using the Ramsey Sedation Score. | 3 days | 
| rate of spontaneous breathing | spontaneous breathing rate per minute | 3 days | 
| possible side effects | open documentation of any side effects like dizziness, vomiting, allergic reaction | 3 days | 
| in hospital stay |  | 1 month | 
| ICU stay |  | 1 month |