Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Aarhus University Hospital

Status: Unknown

Conditions: Pain, Postoperative

Treatments: Drug: Gabapentin group

Study type: Interventional

Funder types: Other

Identifiers

NCT00572208

Gabapentin01

2007-001479-12

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

1

Active Comparator group

Description:

Gabapentin group

Treatment:

Drug: Gabapentin group

2

No Intervention group

Description:

placebo