Oral Oxycodone After Major Cardiac Surgery

NCT01816581 | Completed Phase 4

• 1 other identifier: 1043/2010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• total opioid dosage in terms of so-called morphine equivalents

  total administrated opioid dosage during 3 days after surgery

  3 days

Secondary Outcomes (6)

• VAS pain score

  3 days

• level of sedation

  3 days

• rate of spontaneous breathing

  3 days

• possible side effects

  3 days

• in hospital stay

  1 month

Study Arms (2)

Targin/OxyNorm

ACTIVE COMPARATOR

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

Drug: Targin; Drug: Oxynorm

PCA

ACTIVE COMPARATOR

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

Interventions

Targin DRUG

Also known as: Oxycodonhydrochlorid and naloxone hydrochloride dihydrate

Targin/OxyNorm

Oxynorm DRUG

Also known as: oral medication consisting of Oxycodonhydrochlorid

Targin/OxyNorm

Morphine DRUG

PCA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 24375220 DERIVED

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior staff physician

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 22, 2013
• Study Start: July 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

AU (1)