Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Analgesia

Treatments: Drug: Morphine; Drug: Gabapentin; Drug: Paracetamol; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01966172

Smerte1

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Multimodal

Experimental group

Description:

oral Ibuprofen 400mg 4 times daily oral Gabapentin 300mg twice daily oral Paracetamol 1000mg 4 times daily

Treatment:

Drug: Paracetamol

Drug: Ibuprofen

Drug: Gabapentin

Morphine

Active Comparator group

Description:

oral Morphine 10mg 4 times daily oral paracetamol 1000mg 4 times daily

Treatment:

Drug: Paracetamol

Drug: Morphine