Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01966172

Collaborator

(none)

180

Enrollment

Location

Arms

33.1

Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Mar 1, 2007

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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 Names: 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 Names: An opiod Drug: Paracetamol oral paracetamol 1000mg four times daily

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 Names:

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 Names:

An opiod

Drug: Paracetamol

oral paracetamol 1000mg four times daily

Outcome Measures

Primary Outcome Measures

Evaluation of analgesic effect by 11-NRS scale [4th postoperative day]
assessement of analgesic effect for the first 4 days after surgery

Secondary Outcome Measures

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]
i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation.
Other complications [30th postoperative day]
i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications.
30 day Mortality [30th postoperative day]
Death from all causes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.