Heart; Dysfunction Postoperative, Cardiac SurgeryPhase 4NCT01816581
Oral Oxycodone After Major Cardiac Surgery
A Phase 4 study testing Targin, Oxynorm and Morphine in people with Heart; Dysfunction Postoperative, Cardiac Surgery, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart; Dysfunction Postoperative, Cardiac Surgery
- What is being tested?
- Targin, Oxynorm and Morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2011to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain 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.
- Being tested
- Targin, Oxynorm, Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarginDrug
Also called Oxycodonhydrochlorid and naloxone hydrochloride dihydrate
OxynormDrug
Also called oral medication consisting of Oxycodonhydrochlorid
MorphineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
total opioid dosage in terms of so-called morphine equivalents
total administrated opioid dosage during 3 days after surgery
Measured: 3 days
Secondary outcomes (6)
VAS pain score
Pain Scores on the Visual Analog Scale (0-100)
Measured: 3 days
level of sedation
Level of Sedation using the Ramsey Sedation Score.
Measured: 3 days
rate of spontaneous breathing
spontaneous breathing rate per minute
Measured: 3 days
possible side effects
open documentation of any side effects like dizziness, vomiting, allergic reaction
Measured: 3 days
in hospital stay
Measured: 1 month
ICU stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJul 2011
- Primary completionMay 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart; Dysfunction Postoperative, Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kurt Rutzler, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816581
- Sponsor's protocol ID
- 1043/2010
- Status last verified
- Mar 2014
- First submitted
- 15 Mar 2013
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24375220
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Clinical Pilot Study: Oral Opiate Targin In Treatment Of Postoperative Pain After Major Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01816581
- Acronym / sponsor ID
- 1043/2010
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targin/OxyNorm | Active comparator | Drug: Targin, Drug: OxynormPatients randomized to this study arm will receive Targin as basis pain medication and additional OxyNorm (Oxycodone), if requested by the patients. |
| PCA | Active comparator | Drug: MorphinePatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TarginAlso: Oxycodonhydrochlorid and naloxone hydrochloride dihydrate | Drug | Targin/OxyNorm |
| OxynormAlso: oral medication consisting of Oxycodonhydrochlorid | Drug | Targin/OxyNorm |
| Morphine | Drug | PCA |
Primary outcome
total opioid dosage in terms of so-called morphine equivalents
Time frame: 3 days
total administrated opioid dosage during 3 days after surgery
6 secondary outcomes
VAS pain score
Time frame: 3 days
level of sedation
Time frame: 3 days
rate of spontaneous breathing
Time frame: 3 days
possible side effects
Time frame: 3 days
in hospital stay
Time frame: 1 month
ICU stay
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Derived from this study: PubMed 24375220Ruetzler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Targin, Oxynorm and Morphine in people with Heart; Dysfunction Postoperative, Cardiac Surgery, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total opioid dosage in terms of so-called morphine equivalents (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.