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Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01966172
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):
Sulman Rafiq, Rigshospitalet, Denmark

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Analgesia Postoperative Pain Drug: Ibuprofen Drug: Gabapentin Drug: Morphine Drug: Paracetamol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial
Study Start Date : March 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Multimodal
oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily
 Drug: Ibuprofen
oral ibuprofen 400mg 4 times daily
Other Name: non-selective Non-steroid antiinflammatory drug (NSAID)

Drug: Gabapentin
Oral Gabapentin 300mg twice daily

Drug: Paracetamol
oral paracetamol 1000mg four times daily
Active Comparator: Morphine
oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily
 Drug: Morphine
10 mg morphine orally 4 times daily
Other Name: An opiod

Drug: Paracetamol
oral paracetamol 1000mg four times daily


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of analgesic effect by 11-NRS scale [ Time Frame: 4th postoperative day ]
    assessement of analgesic effect for the first 4 days after surgery


Secondary Outcome Measures :
  1. Additional analgesic consumption [ Time Frame: 4th postoperative day ]
  2. Hospital stay in days. [ Time Frame: days until discharge ]
  3. Evaluation of side-effects by daily questionnaire [ Time Frame: 4th postoperative day ]
  4. Cardiac complications [ Time Frame: 30th postoperative day ]
    i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation.

  5. Other complications [ Time Frame: 30th postoperative day ]
    i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications.

  6. 30 day Mortality [ Time Frame: 30th postoperative day ]
    Death from all causes.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966172


Locations
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Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Peter Skov Olsen, MD,PhD,DMSc Rigshospitalet, Denmark
Study Chair: Sulman Rafiq, MD Rigshospitalet, Denmark
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sulman Rafiq, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01966172    
Other Study ID Numbers: Smerte1
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013
Keywords provided by Sulman Rafiq, Rigshospitalet, Denmark:
NSAID, gabapentin, multimodal, morphine, dexamethasone, cardiac surgery, postoperative pain, analgesia.
Additional relevant MeSH terms:
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Agnosia
Pain, Postoperative
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Pain
Acetaminophen
Ibuprofen
Anti-Inflammatory Agents
Morphine
Gabapentin
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics
Anticonvulsants
Anti-Anxiety Agents