Oral Oxycodone After Major Cardiac Surgery

• ClinicalTrials.gov Identifier: NCT01816581
• Recruitment Status: Completed
• First Posted: March 22, 2013
• Last Update Posted: March 26, 2014
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Kurt Rutzler, Medical University of Vienna

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heart; Dysfunction Postoperative, Cardiac Surgery	Drug: Targin; Drug: Oxynorm; Drug: Morphine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain After Major Cardiac Surgery
• Study Start Date: July 2011
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: March 2013

Arms and Interventions

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.	Drug: Targin; Other Name: Oxycodonhydrochlorid and naloxone hydrochloride dihydrate; Drug: Oxynorm; Other Name: oral medication consisting of Oxycodonhydrochlorid
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.	Drug: Morphine

Outcome Measures

Primary Outcome Measures :

1. total opioid dosage in terms of so-called morphine equivalents [ Time Frame: 3 days ]
   total administrated opioid dosage during 3 days after surgery

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Austria

Medical University Vienna

Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kurt Rutzler, senior staff physician, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT01816581
• Other Study ID Numbers: 1043/2010
• First Posted: March 22, 2013
• Last Update Posted: March 26, 2014
• Last Verified: March 2014

Additional relevant MeSH terms:

Morphine; Naloxone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Narcotic Antagonists