Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial

Conditions
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Analgesia, Postoperative Pain

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Gabapentin
* Drug: Morphine
* Drug: Paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age>18 any cardiac procedure with sternotomy able to give informed consent Exclusion Criteria: cardiac surgery without sternotomy peripheral neuropathy neurological disease psychiatric illness history of GI bleeding chronic pain (i.e. back pain, cancer, arthritis) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal<br>oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily | Drug: Ibuprofen<br>* oral ibuprofen 400mg 4 times daily<br>* Other names: non-selective Non-steroid antiinflammatory drug (NSAID);Drug: Gabapentin<br>* Oral Gabapentin 300mg twice daily<br>Drug: Paracetamol<br>* oral paracetamol 1000mg four times daily<br>|
| Active Comparator: Morphine<br>oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily | Drug: Morphine<br>* 10 mg morphine orally 4 times daily<br>* Other names: An opiod;Drug: Paracetamol<br>* oral paracetamol 1000mg four times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of analgesic effect by 11-NRS scale | assessement of analgesic effect for the first 4 days after surgery | 4th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional analgesic consumption |  | 4th postoperative day | 
| Hospital stay in days. |  | days until discharge | 
| Evaluation of side-effects by daily questionnaire |  | 4th postoperative day | 
| Cardiac complications | i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation. | 30th postoperative day | 
| Other complications | i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications. | 30th postoperative day | 
| 30 day Mortality | Death from all causes. | 30th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSAID, gabapentin, multimodal, morphine, dexamethasone, cardiac surgery, postoperative pain, analgesia.