Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin group
  • 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)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Gabapentin group
• No Intervention: 2
  • placebo

Primary Measures

• Pain
  • Time Frame: 1 month
    Safety Issue?: No
• Morphine consumption
  • Time Frame: 1 month
    Safety Issue?: No

Secondary Measures

• PONV
  • Time Frame: 1 month
    Safety Issue?: No
• Medication side effects
  • Time Frame: 1 month
    Safety Issue?: No
• Hospital stay
  • Time Frame: 1 month
    Safety Issue?: No
• VAS score and medication 30 days after the operation
  • Time Frame: 1 month
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Aarhus University Hospital Other

Overall Clinical Trial Officials and Contacts

Vibeke Hjortdal, MD, Dr.sci Principal Investigator Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby  

Overall Contact: Imran Parvaiz, MD +45 40547377 imran@dadlnet.dk

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00572208

Study ID Number: Gabapentin01

ClinicalTrials.gov Identifier: NCT00572208

Health Authority: Denmark: Danish Medicines Agency