Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery
Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2007
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 30, 2013
CompletedFirst Posted
Study publicly available on registry
October 21, 2013
CompletedOctober 21, 2013
October 1, 2013
2.4 years
September 30, 2013
October 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of analgesic effect by 11-NRS scale
assessement of analgesic effect for the first 4 days after surgery
4th postoperative day
Secondary Outcomes (6)
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
30th postoperative day
Other complications
30th postoperative day
- +1 more secondary outcomes
Study Arms (2)
Multimodal
EXPERIMENTALoral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily
Morphine
ACTIVE COMPARATORoral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily
Interventions
oral ibuprofen 400mg 4 times daily
Eligibility Criteria
You may qualify if:
- age\>18
- any cardiac procedure with sternotomy
- able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet, Copenhagen University Hospital
Copenhagen, 2100, Denmark
Related Publications (1)
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.
PMID: 24650125DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Skov Olsen, MD,PhD,DMSc
Rigshospitalet, Denmark
- STUDY CHAIR
Sulman Rafiq, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 30, 2013
First Posted
October 21, 2013
Study Start
March 1, 2007
Primary Completion
August 1, 2009
Study Completion
December 1, 2009
Last Updated
October 21, 2013
Record last verified: 2013-10