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Completed

NCT Number: NCT02479165

Pain Management After Cardiac Surgery - Opioids or NSAID

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ibuprofene

Drug

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

Oxycodone

Drug

The opioid group is given an oxycodone based analgesic regimen.

Other names: Oxycontin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Pain Management After Cardiac Surgery - Opioids or NSAID? A Randomized Prospective Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
Jun 24, 2015
Registry last updated
Jun 24, 2015

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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