Clinical trial NCT01816581: Oral Oxycodone After Major Cardiac Surgery
Official title: Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain After Major Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: total opioid dosage in terms of so-called morphine equivalents
timeFrame: 3 days
Secondary outcomes:
measure: VAS pain score
timeFrame: 3 days
measure: level of sedation
timeFrame: 3 days
measure: rate of spontaneous breathing
timeFrame: 3 days
measure: possible side effects
timeFrame: 3 days
measure: in hospital stay
timeFrame: 1 month
measure: ICU stay
timeFrame: 1 month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References:
citation: Ruetzler K, Blome CJ, Nabecker S, Makarova N, Fischer H, Rinoesl H, Goliasch G, Sessler DI, Koinig H. A randomised trial of oral versus intravenous opioids for treatment of pain after cardiac surgery. J Anesth. 2014 Aug;28(4):580-6. doi: 10.1007/s00540-013-1770-x. Epub 2013 Dec 28.