Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Pain, Postoperative Clinical Trial

Official title:

Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00572208
• Other study ID #: Gabapentin01
• Secondary ID: 2007-001479-12
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2007
• Last updated: February 12, 2009
• Start date: January 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: University of Aarhus
• Contact: Imran Parvaiz, MD
• Phone: +45 40547377
• Email: imran[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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)

Locations

Country	Name	City	State
Denmark	Cardiothoracic and vascular department, Skejby Sygehus	Aarhus
Denmark	Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		1 month	No
Primary	Morphine consumption		1 month	No
Secondary	PONV		1 month	No
Secondary	Medication side effects		1 month	No
Secondary	Hospital stay		1 month	No
Secondary	VAS score and medication 30 days after the operation		1 month	No