Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Gabapentin group

Group Type ACTIVE_COMPARATOR

Gabapentin group

Intervention Type DRUG

Gabapentin group:

Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)

1. st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
2. nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
3. rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
4. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
5. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)

2

placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gabapentin group

Gabapentin group:

Preoperative (2 h before surgery): Tablet Gabapentin 1200 mg (blinded)

1. st Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
2. nd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
3. rd Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
4. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)
5. th Postoperative day: Tablet Gabapentin 300 mg twice a day (blinded)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No