Myocardial Infarction, Postoperative Pain, Renal Insufficiency
Conditions
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.
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.
Interventions
DRUGIbuprofene
The Ibuprofene group is given an ibuprofen based analgesic regimen, to be compared with the standard opiod based regimen.
DRUGOxycodone
The opioid group is given an oxycodone based analgesic regimen.
Sponsors
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score - Visual Analouge Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Nausea, Hours | 5 days | At noon, the total hours of nausea over the previous 24h is noted. Registration until discharge, average 5th postoperative day. |
| Vomiting, events pr. 24 hours | 5 days. | Number of themes the patient has vomitted is noted. Registration until discharge, average 5th postoperative day. |
| Hallucination, events pr. 24 hours | 5 days | At noon, it is recorded wether the patient has experienced hallucinations the previous 24h. Registration until discharge, average 5th postoperative day. |
| Confusion | 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. |
| Opioid antidote | 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. |
| Bowel movement, hours until movement | 5 days | Time is noted of first bowel movement. Registration until discharge, average 5th postoperative day. |
| Myocardial Infarction, no. of cases | 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. |
| All cause mortality | 36 months | All cause mortality until followup. |
| Sternal non-union, no of cases | 36 months | Sternal non-union from 1 month after surgery until followup. |
| Gastro-intestinal bleeding, no. of cases | 36 months | Bleeding verified through gastroscopi or colonoscopi from operation until followup. |
| Degree of mobilization, Mobilization scale | 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. |
| Renal function as serum-creatinine (micromol/l) | 36 months | Se-creatinine recorded on the morning of postoperative day 1, 2 and 4 and as out-patient at followup. |
Outcome results
None listed