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Pain Management After Cardiac Surgery - Opioids or NSAID

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ClinicalTrials.gov Identifier: NCT02479165
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Martin Agge Nørgaard, Aalborg University Hospital

Brief Summary:
The aim of this randomized controlled study is to shed light on the analgesic properties and side-effect profile of an opiod-based regimen as opposed to an Ibuprofene based regimen.

Condition or disease Intervention/treatment Phase
Postoperative Pain Renal Insufficiency Myocardial Infarction Drug: Ibuprofene Drug: Oxycodone Phase 4

Detailed Description:

Background:

Postoperative pain following median sternotomy can represent a major postoperative problem as it can lead to reduced mobilization and shallow, restricted breathing and insufficient cough, which can lead to pulmonary complications.

However, pain management with opioids has frequent side-effects such as confusion, respiratory depression, sedation, nausea and obstipation/ paralytic ilieus. Non-steroid anti-inflammatory drugs (NSAIDs) can been used as opiod-sparing analgesics following cardiac surgery. However, this remains controversial, as NSAIDs has been linked to an increased risk of myocardial infarction, especially in patients with ischaemic heart disease, renal failure, gastrointestinal bleeding, and possibly impaired sternal healing.

The investigators wanted to investigate the analgesic properties of a opiod-based regimen with that of an ibuprofene-based, through randomization of patients to one of the two arms.

Intervention:

The participants were given analgesics in accordance to their randomization group upon return from the postoperative ICU stay.

The opioid regimen relied on a basic dose of slow-release oxycodone ("Oxycontin", Norpharma, Vedbaek, Denmark, 10mg two times daily) and paracetamol ("Panodil", GlaxoSmithKline, Copenhagen, Denmark, 1g four times daily). For "break-through pain" extra oxycodone was administered as injections or capsules (5mg pr. dose). Furthermore laxatives were co-administered to prevent obstipation.

In the ibuprofene regimen slow-release ibuprofen ("Brufen Retard", Abbott, Copenhagen, Denmark, 800mg two times daily) replaced oxycodone as the basic analgesic. In the ibuprofene regimen lansoprazol ("Lansoprazole", Actavis, Gentofte, Denmark, 30mg once daily) was co-administered to prevent development of gastric ulcers. These regimens were initiated the first postoperative day, when the patient was transferred from the ICU to the ward, and continued until the seventh postoperative day. Some patient

Outcome:

Please refer to the "outcome" chapter

Statistics:

Data are presented as number of patients, medians, and ranges. Patients are compared according to the ibuprofen or the oxycodone group, and statistics were done using "intention-to-treat"-design. Fischer's exact test, Mann-Whitney, and 95% confidence intervals were used as appropriate. Significance was defined as P-values below 0.05.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Management After Cardiac Surgery - Opioids or NSAID? A Randomized Prospective Study
Study Start Date : May 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Opioid group

If randomized to the opiod group, the patient was given the following regimen for 1 week, upon return from the intensive care unit, after surgery.

Tbl. Oxycodone (slow-release) 10mg, Twice daily for 1 week Tbl. Paracetamol 1000mg, Four times daily for 1 week Tbl.oxycodone 5mg Max 4 times daily, as needed, until discharge. Inj, oxycodone 2.5 mg, Max 4 times daily, as needed, until discharge Tbl. Magnesia 1g, Twice daily, for 1 week Sol. Sodiumpicosulfate 7.5mg/ml 10 drops daily, for 1 week

Drug: Oxycodone
The opioid group is given an oxycodone based analgesic regimen.
Other Name: Oxycontin

Active Comparator: Ibuprofene group

If randomized to the ibuprofen group, the patient was given the following regimen for 1 week, upon return from the intensive care unit, after surgery.

Tbl. Ibuprofen (slow-release) 800mg, Twice daily, for 1 week Tbl. Paracetamol 1000mg, Four times daily, for 1 week Tbl.oxycodone 5mg Max 4 times daily, as needed. Until discharge. Inj, oxycodone 2.5 mg Max 4 times daily, as needed. Until discharge. Tbl. Lanzoprazole 40 mg, Once daily, for 1 week Tbl. Magnesia 1g, Twice daily, for 1 week Sol. Sodiumpicosulfate 7.5mg/ml, 10 drops daily, for 1 week

Drug: Ibuprofene
The Ibuprofene group is given an ibuprofen based analgesic regimen, to be compared with the standard opiod based regimen.
Other Names:
  • Ipren
  • Advil
  • Motrin
  • Nurofen




Primary Outcome Measures :
  1. Pain score - Visual Analouge Scale [ Time Frame: 5 days ]
    Visual analouge scale from 0-10, recorded at noon every day. Given as average/minimum/maximum previous 24h by patient. Until discharge, average 5th postoperative day.


Secondary Outcome Measures :
  1. Bowel movement, hours until movement [ Time Frame: 5 days ]
    Time is noted of first bowel movement. Registration until discharge, average 5th postoperative day.

  2. Nausea, Hours [ Time Frame: 5 days ]
    At noon, the total hours of nausea over the previous 24h is noted. Registration until discharge, average 5th postoperative day.

  3. Vomiting, events pr. 24 hours [ Time Frame: 5 days. ]
    Number of themes the patient has vomitted is noted. Registration until discharge, average 5th postoperative day.

  4. Hallucination, events pr. 24 hours [ Time Frame: 5 days ]
    At noon, it is recorded wether the patient has experienced hallucinations the previous 24h. Registration until discharge, average 5th postoperative day.

  5. Confusion [ Time Frame: 5 days ]
    At noon, it is recorded wether the patient can name the given time, physical location own social security number. Registration until discharge, average 5th postoperative day.

  6. Opioid antidote [ Time Frame: 5 days ]
    At noon, it is recorded if the patient is given opiod antagonists (such as Naloxone) the previous 24h. Registration until discharge, average 5th postoperative day.

  7. Renal function as serum-creatinine (micromol/l) [ Time Frame: 36 months ]
    Se-creatinine recorded on the morning of postoperative day 1, 2 and 4 and as out-patient at followup.

  8. Myocardial Infarction, no. of cases [ Time Frame: 36 months ]
    Postoperative myocardial infarction according to ESC/ACC/AHA/WHF consensus-report. Registration until discharge, average 5th postoperative day, and as outpatients until followup.

  9. All cause mortality [ Time Frame: 36 months ]
    All cause mortality until followup.

  10. Sternal non-union, no of cases [ Time Frame: 36 months ]
    Sternal non-union from 1 month after surgery until followup.

  11. Gastro-intestinal bleeding, no. of cases [ Time Frame: 36 months ]
    Bleeding verified through gastroscopi or colonoscopi from operation until followup.

  12. Degree of mobilization, Mobilization scale [ Time Frame: 5 days ]
    At noon, the degree of mobilization is noted on an scale from 0 (complete immobilization) - 4 (complete mobilization). Registration until discharge, average 5th postoperative day.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac surgery through median sternotomy
  • Written consent
  • Age over 18 years

Exclusion Criteria:

  • Other forms of sternotomy (i.e. re-sternotomy or partial sternotomy)
  • Preoperative creatinine over 110 µmol/L
  • Preoperative use of opioids or NSAIDs in analgesic doses (aspirin in antithrombotic doses was accepted)
  • Allergy to NSAIDs or opioids, and other contraindications to the used drugs

The postoperative exclusion criteria were:

  • Staying more than one night at the intensive care unit
  • Unacceptable side effects
  • Exclusion at the patients request

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479165


Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Principal Investigator: Martin A Norgaard, DMsc Dep. of cardiothoracic surgery, Aalborg university hospital, Denmark

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Responsible Party: Martin Agge Nørgaard, MD, DMsc, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT02479165     History of Changes
Other Study ID Numbers: The NSAID trial
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Pain, Postoperative
Renal Insufficiency
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Analgesics, Opioid
Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents