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Completed

NCT Number: NCT01816581

Oral Oxycodone After Major Cardiac Surgery

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.

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Key information

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targin

Drug

Other names: Oxycodonhydrochlorid and naloxone hydrochloride dihydrate

OxyNorm

Drug

Other names: oral medication consisting of Oxycodonhydrochlorid

Morphine

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 22, 2013
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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