Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Drug: Gabapentin group

• Registration Number: NCT00572208
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-12
• Study Start: 2008-01
• Status Verified: 2009-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-12
• Last Update Posted: 2009-02-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gabapentin group	Gabapentin group

Primary Outcome Measures

Name	Time	Method
Morphine consumption	1 month
Pain	1 month

Secondary Outcome Measures

Name	Time	Method
PONV	1 month
Medication side effects	1 month
Hospital stay	1 month
VAS score and medication 30 days after the operation	1 month

Trial Locations

Locations (2)

Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark

Cardiothoracic and vascular department, Skejby Sygehus; 🇩🇰 Aarhus, Denmark