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OpenTrials
Completed

NCT Number: NCT01966172

Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery

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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ibuprofen

Drug

oral ibuprofen 400mg 4 times daily

Other names: non-selective Non-steroid antiinflammatory drug (NSAID)

Gabapentin

Drug

Oral Gabapentin 300mg twice daily

Morphine

Drug

10 mg morphine orally 4 times daily

Other names: An opiod

Paracetamol

Drug

oral paracetamol 1000mg four times daily

Primary outcomes

  1. Evaluation of analgesic effect by 11-NRS scale

    Time frame: 4th postoperative day

    assessement of analgesic effect for the first 4 days after surgery

Secondary outcomes

  1. Additional analgesic consumption

    Time frame: 4th postoperative day

  2. Hospital stay in days.

    Time frame: days until discharge

  3. Evaluation of side-effects by daily questionnaire

    Time frame: 4th postoperative day

  4. Cardiac complications

    Time frame: 30th postoperative day

    i.e. Myocardial infarction(MI), postoperative pericardial effusion, heart failure requiring inotropic support , atrial fibrillation.

  5. Other complications

    Time frame: 30th postoperative day

    i.e. cerebral (stroke, bleeding), GI(bleeding), blood component requirements and sternal complications.

  6. 30 day Mortality

    Time frame: 30th postoperative day

    Death from all causes.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 21, 2013
Registry last updated
Oct 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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