Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Study Overview
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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.

Official Title
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Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Gabapentin group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for elective cardiac surgery with median sternotomy at the department of cardiac surgery, Aarhus University Hospital, Skejby. Patients older than 18 years. Exclusion Criteria: Patients unable to cooperate. Known allergy for Gabapentin or opioids. Acute pancreatitis History of gastric or peptic ulcer. History of alcohol or drug abuse. Chronic pain or daily intake of analgesics or corticosteroids. Gastrointestinal obstruction Impaired liver function. Impaired kidney function. Previous operation with median sternotomy Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Gabapentin group | Drug: Gabapentin group<br>* 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)<br>|
| No Intervention: 2<br>placebo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 1 month | 
| Morphine consumption |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PONV |  | 1 month | 
| Medication side effects |  | 1 month | 
| Hospital stay |  | 1 month | 
| VAS score and medication 30 days after the operation |  | 1 month |