Postoperative PainPhase 4NCT02479165
Pain Management After Cardiac Surgery - Opioids or NSAID
A Phase 4 study testing Ibuprofene and Oxycodone in people with Postoperative Pain and Renal Insufficiency, run by Aalborg University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Renal Insufficiency, Myocardial Infarction
- What is being tested?
- Ibuprofene and Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac surgery through median sternotomy
- Written consent
- Age over 18 years
Who cannot join
- 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
About this study
Official title: Pain Management After Cardiac Surgery - Opioids or NSAID? A Randomized Prospective Study
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.
Read the 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.
- Being tested
- Ibuprofene, Oxycodone
- Medical subject headings
- Pain, Postoperative, Renal Insufficiency, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofeneDrug
Also called Ipren, Advil, Motrin, Nurofen
The Ibuprofene group is given an ibuprofen based analgesic regimen, to be compared with the standard opiod based regimen.
OxycodoneDrug
Also called Oxycontin
The opioid group is given an oxycodone based analgesic regimen.
| Study group | Role | What they receive |
|---|---|---|
| Opioid group | Active comparator | 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 Receives: Drug: Oxycodone |
| Ibuprofene group | Active comparator | 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 Receives: Drug: Ibuprofene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (12)
Bowel movement, hours until movement
Time is noted of first bowel movement. Registration until discharge, average 5th postoperative day.
Measured: 5 days
Nausea, Hours
At noon, the total hours of nausea over the previous 24h is noted. Registration until discharge, average 5th postoperative day.
Measured: 5 days
Vomiting, events pr. 24 hours
Number of themes the patient has vomitted is noted. Registration until discharge, average 5th postoperative day.
Measured: 5 days.
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.
Measured: 5 days
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.
Measured: 5 days
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.
Measured: 5 days
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.
Measured: 36 months
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.
Measured: 36 months
All cause mortality
All cause mortality until followup.
Measured: 36 months
Sternal non-union, no of cases
Sternal non-union from 1 month after surgery until followup.
Measured: 36 months
Gastro-intestinal bleeding, no. of cases
Bleeding verified through gastroscopi or colonoscopi from operation until followup.
Measured: 36 months
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startMay 2009
- Primary completionSep 2010
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Agge Nørgaard, Aalborg University Hospital
- Investigators
- Martin A Norgaard, DMsc, Principal investigator, Dep. of cardiothoracic surgery, Aalborg university hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479165
- Sponsor's protocol ID
- The NSAID trial
- Status last verified
- Jun 2015
- First submitted
- 31 Mar 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management After Cardiac Surgery - Opioids or NSAID? A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02479165
- Acronym / sponsor ID
- The NSAID trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Jun 2015 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid group | Active comparator | Drug: OxycodoneIf 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 |
| Ibuprofene group | Active comparator | Drug: IbuprofeneIf 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cardiac surgery through median sternotomy
- Written consent
- Age over 18 years
Key exclusion criteria (7 listed)
- 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
- Staying more than one night at the intensive care unit
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 |
|---|---|---|
| IbuprofeneAlso: Ipren, Advil, Motrin, NurofenThe Ibuprofene group is given an ibuprofen based analgesic regimen, to be compared with the standard opiod based regimen. | Drug | Ibuprofene group |
| OxycodoneAlso: OxycontinThe opioid group is given an oxycodone based analgesic regimen. | Drug | Opioid group |
Primary outcome
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.
12 secondary outcomes
Bowel movement, hours until movement
Time frame: 5 days
Nausea, Hours
Time frame: 5 days
Vomiting, events pr. 24 hours
Time frame: 5 days.
Hallucination, events pr. 24 hours
Time frame: 5 days
Confusion
Time frame: 5 days
Opioid antidote
Time frame: 5 days
Renal function as serum-creatinine (micromol/l)
Time frame: 36 months
Myocardial Infarction, no. of cases
Time frame: 36 months
All cause mortality
Time frame: 36 months
Sternal non-union, no of cases
Time frame: 36 months
Gastro-intestinal bleeding, no. of cases
Time frame: 36 months
Degree of mobilization, Mobilization scale
Time frame: 5 days
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 24 Jun 2015.
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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.
Martin A Norgaard, DMsc principal investigator
Dep. of cardiothoracic surgery, Aalborg university hospital, Denmark
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofene and Oxycodone in people with Postoperative Pain and Renal Insufficiency, run by Aalborg University Hospital.
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 3 inclusion and 7 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain score - Visual Analouge Scale (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2015.