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Clinical Trial Name - Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

 
Original Study ID : Gabapentin01
Secondary ID : 2007-001479-12
NCT ID : NCT00572208
Brief Title : Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
Official Title : Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
Brief Summary :

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.

Source : University of Aarhus
Overall Status : Recruiting
Start Date : January 2008
End Date : February 2009
Completion Date : February 2009
Official Title : N/A
Phase : Interventional
Study Design : Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Enrollment : 64
Verification Date : February 2009
First Received Date : December 11, 2007
Trial Eligibility
Criteria :
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
Gender : Both
Minimum Age : 18 Years
Maximum Age : N/A
Healthy Volunteers : No
Facilities
Facility Name : Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
Status : Not yet recruiting
City : Aarhus
Zip Code : 8200
Country : Denmark
Facility Name : Cardiothoracic and vascular department, Skejby Sygehus
Status : Recruiting
City : Aarhus
Zip Code : 8200
Country : Denmark
OutComes
Primary OutComes
Secondary OutComes
Measure : PONV
Time Frame : 1 month
Safety issue : No
Measure : Medication side effects
Time Frame : 1 month
Safety issue : No
Measure : Hospital stay
Time Frame : 1 month
Safety issue : No
Measure : VAS score and medication 30 days after the operation
Time Frame : 1 month
Safety issue : No
Interventions
Type : Drug
Name : Gabapentin group
Description : Gabapentin group: Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded) st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded) th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
 
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