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Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

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ClinicalTrials.gov Identifier: NCT00572208
Recruitment Status : Unknown
Verified February 2009 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : December 12, 2007
Last Update Posted : February 13, 2009
Sponsor:
Information provided by:

December 11, 2007
December 12, 2007
February 13, 2009
January 2008
February 2009   (Final data collection date for primary outcome measure)
  • Pain [ Time Frame: 1 month ]
  • Morphine consumption [ Time Frame: 1 month ]
Same as current
Complete list of historical versions of study NCT00572208 on ClinicalTrials.gov Archive Site
  • PONV [ Time Frame: 1 month ]
  • Medication side effects [ Time Frame: 1 month ]
  • Hospital stay [ Time Frame: 1 month ]
  • VAS score and medication 30 days after the operation [ Time Frame: 1 month ]
Same as current
Not Provided
Not Provided
 
Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

In this study we will focus on the postoperative recovery. A successful postoperative recovery should bring the patient to at least to the pre-surgical level. This can probably be achieved by a multimodal approach where at least postoperative pain and PONV are managed.

The surgical injury results in immobilisation which again can result in impaired cardiac, respiratory and musculoskeletal system. Pain relief is a prerequisite for mobilisation and an early return to the pre-surgical level. The preferred drugs for postoperative pain management are opioids. Although opioids are known to be an effective analgesia, they have a series of side effects: nausea, vomiting, constipation, respiratory deficiency, delirium among others.

Gabapentin has been tested for post operative pain. Randomized Clinical Trials have reported a significant better pain scores with Gabapentin in several studies -most of them restricted to the postoperative period in the post-anaesthesia care unit in many different kind of surgeries.

We want to test if Gabapentin can be used instead of opioids for treatment of postoperative pain after heart surgery by median sternotomy.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain, Postoperative
Drug: Gabapentin group

Gabapentin group:

Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)

  1. st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
  2. nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
  3. rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
  4. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
  5. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
  • Active Comparator: 1
    Gabapentin group
    Intervention: Drug: Gabapentin group
  • No Intervention: 2
    placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
64
February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients scheduled for elective cardiac surgery with median sternotomy at the department of cardiac surgery, Aarhus University Hospital, Skejby.
  2. Patients older than 18 years.

Exclusion Criteria:

  1. Patients unable to cooperate.
  2. Known allergy for Gabapentin or opioids.
  3. Acute pancreatitis
  4. History of gastric or peptic ulcer.
  5. History of alcohol or drug abuse.
  6. Chronic pain or daily intake of analgesics or corticosteroids.
  7. Gastrointestinal obstruction
  8. Impaired liver function.
  9. Impaired kidney function.
  10. Previous operation with median sternotomy
  11. Pregnant women
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00572208
Gabapentin01
2007-001479-12
Yes
Not Provided
Not Provided
Vibeke Hjortdal, Professor, Consultant, Dr. Sci., PhD., Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
Aarhus University Hospital
Not Provided
Principal Investigator: Vibeke Hjortdal, MD, Dr.sci Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
University of Aarhus
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP