Oral Oxycodone After Major Cardiac Surgery

NCT ID: NCT01816581

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-03-31

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.

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Targin/OxyNorm

Patients randomized to this study arm will receive Targin as basis pain medication and additional OxyNorm (Oxycodone), if requested by the patients.

Group Type: ACTIVE_COMPARATOR

Targin

Intervention Type: DRUG

Oxynorm

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Interventions

Targin

Intervention Type: DRUG

Oxynorm

Intervention Type: DRUG

Morphine

Intervention Type: DRUG

Other Intervention Names

Oxycodonhydrochlorid and naloxone hydrochloride dihydrate; oral medication consisting of Oxycodonhydrochlorid

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Kurt Rutzler

senior staff physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University Vienna

Vienna, Vienna, Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 24375220 (View on PubMed)

Other Identifiers

1043/2010

Identifier Type: -

Identifier Source: org_study_id