Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery | RxWiki

Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

Overview[ - collapse ][ - ]

Purpose	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	Analgesia Postoperative Pain
Intervention	Drug: Ibuprofen Drug: Gabapentin Drug: Morphine Drug: Paracetamol
Phase	Phase 4
Sponsor	Rigshospitalet, Denmark
Responsible Party	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier	NCT01966172
First Received	September 30, 2013
Last Updated	October 16, 2013
Last verified	October 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 30, 2013
Last Updated Date	October 16, 2013
Start Date	March 2007
Estimated Primary Completion Date	December 2009
Current Primary Outcome Measures	Evaluation of analgesic effect by 11-NRS scale [Time Frame: 4th postoperative day] [Designated as safety issue: No]assessement of analgesic effect for the first 4 days after surgery
Current Secondary Outcome Measures	Additional analgesic consumption [Time Frame: 4th postoperative day] [Designated as safety issue: No] Hospital stay in days. [Time Frame: days until discharge] [Designated as safety issue: No] Evaluation of side-effects by daily questionnaire [Time Frame: 4th postoperative day] [Designated as safety issue: No] Cardiac complications [Time Frame: 30th postoperative day] [Designated as safety issue: Yes]i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation. Other complications [Time Frame: 30th postoperative day] [Designated as safety issue: Yes]i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications. 30 day Mortality [Time Frame: 30th postoperative day] [Designated as safety issue: Yes]Death from all causes.

Descriptive Information[ + expand ][ + ]

Brief Title	Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery
Official Title	Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Condition	Analgesia Postoperative Pain
Intervention	Drug: Ibuprofen oral ibuprofen 400mg 4 times daily Other Names: non-selective Non-steroid antiinflammatory drug (NSAID)Drug: Gabapentin Oral Gabapentin 300mg twice daily Drug: Morphine 10 mg morphine orally 4 times daily Other Names: An opiodDrug: Paracetamol oral paracetamol 1000mg four times daily
Study Arm (s)	Experimental: Multimodal oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily Active Comparator: Morphine oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	180
Estimated Completion Date	December 2009
Estimated Primary Completion Date	August 2009
Eligibility 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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Denmark

Administrative Information[ + expand ][ + ]

NCT Number	NCT01966172
Other Study ID Numbers	Smerte1
Has Data Monitoring Committee	No
Information Provided By	Rigshospitalet, Denmark
Study Sponsor	Rigshospitalet, Denmark
Collaborators	Not Provided
Investigators	Principal Investigator: Peter Skov Olsen, MD,PhD,DMSc Rigshospitalet, DenmarkStudy Chair: Sulman Rafiq, MD Rigshospitalet, Denmark
Verification Date	October 2013

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