Pain Management After Cardiac Surgery - Opioids or NSAID

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479165
• Other study ID #: The NSAID trial
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2015
• Last updated: June 19, 2015
• Start date: May 2009
• Est. completion date: September 2013

Study information

• Verified date: June 2015
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Infarction
• Pain, Postoperative
• Postoperative Pain
• Renal Insufficiency

Intervention

Drug:
• Ibuprofene
The Ibuprofene group is given an ibuprofen based analgesic regimen, to be compared with the standard opiod based regimen.
• Oxycodone
The opioid group is given an oxycodone based analgesic regimen.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score - Visual Analouge Scale	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.	5 days	No
Secondary	Bowel movement, hours until movement	Time is noted of first bowel movement. Registration until discharge, average 5th postoperative day.	5 days	No
Secondary	Nausea, Hours	At noon, the total hours of nausea over the previous 24h is noted. Registration until discharge, average 5th postoperative day.	5 days	No
Secondary	Vomiting, events pr. 24 hours	Number of themes the patient has vomitted is noted. Registration until discharge, average 5th postoperative day.	5 days.	No
Secondary	Hallucination, events pr. 24 hours	At noon, it is recorded wether the patient has experienced hallucinations the previous 24h. Registration until discharge, average 5th postoperative day.	5 days	No
Secondary	Confusion	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.	5 days	No
Secondary	Opioid antidote	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.	5 days	No
Secondary	Renal function as serum-creatinine (micromol/l)	Se-creatinine recorded on the morning of postoperative day 1, 2 and 4 and as out-patient at followup.	36 months	Yes
Secondary	Myocardial Infarction, no. of cases	Postoperative myocardial infarction according to ESC/ACC/AHA/WHF consensus-report. Registration until discharge, average 5th postoperative day, and as outpatients until followup.	36 months	Yes
Secondary	All cause mortality	All cause mortality until followup.	36 months	Yes
Secondary	Sternal non-union, no of cases	Sternal non-union from 1 month after surgery until followup.	36 months	Yes
Secondary	Gastro-intestinal bleeding, no. of cases	Bleeding verified through gastroscopi or colonoscopi from operation until followup.	36 months	Yes
Secondary	Degree of mobilization, Mobilization scale	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.	5 days	No