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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin 75 | Experimental | Pregabalin 75mg by mouth one hour before surgery |
|
| Pregabalin 150 | Active Comparator | Pregabalin 150mg by mouth one hour before surgery |
|
| Sugar pill | Placebo Comparator | Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 75mg | Drug | Pregabalin 75mg by mouth one hour before surgery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aikaterini A Bouzia, Medicine | PhD candidate, School of Medicine, Univercity of Larissa | Principal Investigator |
| Georgios Vretzakis, Medicine | Associate Professor of Anaesthesiology, Schooll of Medicine, University of Larissa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univercity Hospital of Larissa | Larissa | Thessaly | 41110 | Greece |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| pregabalin 150 mg | Drug | pregabalin 150mg by mouth one hour before surgery |
|
|
| Placebo | Drug | Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |