AnalgesiaPhase 4NCT01966172
Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery
A Phase 4 study testing Ibuprofen, Gabapentin and Morphine in people with Analgesia and Postoperative Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
To test if multimodal analgesia with different analgesic medication offer better pain relief, lesser side effects and is safe compared to conventionel opiod analgesia after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Postoperative Pain
- What is being tested?
- Ibuprofen, Gabapentin and Morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Dec 2009
- 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
- age>18
- any cardiac procedure with sternotomy
- able to give informed consent
Who cannot join
- cardiac surgery without sternotomy
- peripheral neuropathy
- neurological disease
- psychiatric illness
- history of GI bleeding
- chronic pain (i.e. back pain, cancer, arthritis)
Show all 15Show fewer
- serum creatinine >150 μmol/l
- hepatic disease with elevated liver enzymes (SGPT and SGOT elevated to 1.5 times maximum normal value)
- allergic to study medication
- alcohol abuse
- abuse of narcotics or medication
- pregnancy
- participation in other clinical trials
- insufficient language skills
- In addition intensive care unit (ICU) stay for more than 24 hours was used as a pre-defined post randomization exclusion criteria, because prolonged ICU stay and ventilator treatment would interfere with study analgesic protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial
To test if multimodal analgesia with different analgesic medication offer better pain relief, lesser side effects and is safe compared to conventionel opiod analgesia after cardiac surgery.
- Conditions
- Analgesia, Postoperative Pain
- Being tested
- Ibuprofen, Gabapentin, Morphine, Paracetamol
- Keywords
- NSAID, gabapentin, multimodal, morphine, dexamethasone, cardiac surgery, postoperative pain, analgesia.
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called non-selective Non-steroid antiinflammatory drug (NSAID)
oral ibuprofen 400mg 4 times daily
GabapentinDrug
Oral Gabapentin 300mg twice daily
MorphineDrug
Also called An opiod
10 mg morphine orally 4 times daily
ParacetamolDrug
oral paracetamol 1000mg four times daily
| Study group | Role | What they receive |
|---|---|---|
| Multimodal | Experimental | oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily Receives: Drug: Ibuprofen; Drug: Gabapentin; Drug: Paracetamol |
| Morphine | Active comparator | oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily Receives: Drug: Morphine; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of analgesic effect by 11-NRS scale
assessement of analgesic effect for the first 4 days after surgery
Measured: 4th postoperative day
Secondary outcomes (6)
Additional analgesic consumption
Measured: 4th postoperative day
Hospital stay in days.
Measured: days until discharge
Evaluation of side-effects by daily questionnaire
Measured: 4th postoperative day
Cardiac complications
i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation.
Measured: 30th postoperative day
Other complications
i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications.
Measured: 30th postoperative day
30 day Mortality
Death from all causes.
Measured: 30th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startMar 2007
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sulman Rafiq, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Peter Skov Olsen, MD,PhD,DMSc, Principal investigator, Copenhagen University Hospital, RigshospitaletSulman Rafiq, MD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966172
- Sponsor's protocol ID
- Smerte1
- Status last verified
- Oct 2013
- First submitted
- 30 Sep 2013
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rafiq S, Steinbruchel DA, Wanscher MJ, Andersen LW, Navne A, Lilleoer NB, Olsen PS. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial. J Cardiothorac Surg. 2014 Mar 20;9:52. doi: 10.1186/1749-8090-9-52.
PubMed 24650125
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01966172
- Acronym / sponsor ID
- Smerte1
- Conditions
- Analgesia, Postoperative Pain
- Keywords
- NSAID, gabapentin, multimodal, morphine, dexamethasone, cardiac surgery, postoperative pain, analgesia.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Oct 2013 (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.
To test if multimodal analgesia with different analgesic medication offer better pain relief, lesser side effects and is safe compared to conventionel opiod analgesia after cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal | Experimental | Drug: Ibuprofen, Drug: Gabapentin, Drug: Paracetamoloral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily |
| Morphine | Active comparator | Drug: Morphine, Drug: Paracetamoloral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age>18
- any cardiac procedure with sternotomy
- able to give informed consent
Key exclusion criteria (15 listed)
- cardiac surgery without sternotomy
- peripheral neuropathy
- neurological disease
- psychiatric illness
- history of GI bleeding
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 |
|---|---|---|
| IbuprofenAlso: non-selective Non-steroid antiinflammatory drug (NSAID)oral ibuprofen 400mg 4 times daily | Drug | Multimodal |
| GabapentinOral Gabapentin 300mg twice daily | Drug | Multimodal |
| MorphineAlso: An opiod10 mg morphine orally 4 times daily | Drug | Morphine |
| Paracetamoloral paracetamol 1000mg four times daily | Drug | Morphine, Multimodal |
Primary outcome
Evaluation of analgesic effect by 11-NRS scale
Time frame: 4th postoperative day
assessement of analgesic effect for the first 4 days after surgery
6 secondary outcomes
Additional analgesic consumption
Time frame: 4th postoperative day
Hospital stay in days.
Time frame: days until discharge
Evaluation of side-effects by daily questionnaire
Time frame: 4th postoperative day
Cardiac complications
Time frame: 30th postoperative day
Other complications
Time frame: 30th postoperative day
30 day Mortality
Time frame: 30th postoperative day
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 21 Oct 2013.
- Derived from this study: PubMed 24650125Rafiq S, Steinbruchel DA, Wanscher MJ, Andersen LW, Navne A, Lilleoer NB, Olsen PS. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial. J Cardiothorac Surg. 2014 Mar 20;9:52. doi: 10.1186/1749-8090-9-52.
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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.
Peter Skov Olsen, MD,PhD,DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
Sulman Rafiq, MD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen, Gabapentin and Morphine in people with Analgesia and Postoperative Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 15 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 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Evaluation of analgesic effect by 11-NRS scale (time frame: 4th postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01966172, which also lists 1 linked publication.
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 21 Oct 2013.