Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

Phase 4

Completed

• Conditions: Postoperative Pain; Analgesia
• Interventions: Drug: Ibuprofen; Drug: Morphine; Drug: Gabapentin; Drug: Paracetamol

• Registration Number: NCT01966172
• Lead Sponsor: Rigshospitalet, Denmark

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 available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Study First Submitted: 2013-09-30
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-16
• Last Update Submitted: 2013-10-16
• Study First Posted: 2013-10-21
• Last Update Posted: 2013-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal	Gabapentin	oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily
Multimodal	Ibuprofen	oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily
Multimodal	Paracetamol	oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily
Morphine	Morphine	oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily
Morphine	Paracetamol	oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Rigshospitalet, Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark