The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine whether pregabalin is effective in the treatment of acute postoperative pain after cardiac surgery if administered before the surgery.

Detailed Description
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Pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and anxiolytic properties and was also used to treat neuropathic pain. In recent years it has been used as part of a multimodal management of acute postoperative pain after various types of surgery. We study the effect of pregabalin administered before cardiac surgery on acute and chronic postoperative pain. Post CABG syndrome is well known since 1980 and various analgesic methods have been used from time to time (opioids, regional analgesia, non-steroidal anti-inflammatory drugs). In our research patients will be divided into three groups. The control group will receive a placebo capsule before surgery. The second group will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of pregabalin. After the surgery all patients will be connected to an intravenous PCA morphine pump for 48 hours. The postoperative pain will be assessed with the Visual Analogue Scale (0-10) every day. Total morphine consumption by the patients as well as any other pain medications administered supplementary will be registered and compared between the different groups. Remaining postoperative pain will be assessed after 3 months. The results will be statistically analyzed in order to determine whether there is significant difference in pain management between the groups.

Official Title
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The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Pregabalin 75mg
* Drug: pregabalin 150 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients' age 18-85years who are undergoing cardiac surgery Exclusion Criteria: Chronic pain syndromes Renal failure Age >85 Allergy to Pregabalin Patients already taking pregabalin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin 75<br>Pregabalin 75mg by mouth one hour before surgery | Drug: Pregabalin 75mg<br>* Pregabalin 75mg by mouth one hour before surgery<br>* Other names: Lyrica;|
| Active Comparator: Pregabalin 150<br>Pregabalin 150mg by mouth one hour before surgery | Drug: pregabalin 150 mg<br>* pregabalin 150mg by mouth one hour before surgery<br>* Other names: Lyrica;|
| Placebo Comparator: Sugar pill<br>Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery | Drug: Placebo<br>* Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption and other analgesics after surgery | Patients will be questioned about postoperative pain and opioid consumption will be measured during the first 24 hours after surgery. Other analgesics they may receive will also be recorded. | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remaining surgery related pain and analgesics consumption | Patients will be questioned three month after surgery about the presence of post operative pain, whether it affects their quality of life and whether they are receiving pain treatment | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, pregabalin, postoperative pain