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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Analgesia
• Intervention / Treatment: Drug: Ibuprofen; Drug: Gabapentin; Drug: Paracetamol; Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, Copenhagen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Paracetamol; oral paracetamol 1000mg four times daily; Drug: Morphine; 10 mg morphine orally 4 times daily; Other Names: An opiod

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of analgesic effect by 11-NRS scale	assessement of analgesic effect for the first 4 days after surgery	4th postoperative day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Peter Skov Olsen, MD,PhD,DMSc, Rigshospitalet, Denmark; Study Chair: Sulman Rafiq, MD, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: October 16, 2013
• First Posted (Estimate): October 21, 2013

Study Record Updates

• Last Update Posted (Estimate): October 21, 2013
• Last Update Submitted That Met QC Criteria: October 16, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: NSAID, gabapentin, multimodal, morphine, dexamethasone, cardiac surgery, postoperative pain, analgesia.
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Agnosia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin; Anti-Inflammatory Agents; Acetaminophen; Morphine; Ibuprofen
• Other Study ID Numbers: Smerte1