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We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. Do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS and a greater QoR score in the first 24 hours after their surgery than those women who received placebo?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Lactulose Placebo |
| |
| Pregabalin 150 mg |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald B George, MD FRCPC | IWK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Drug |
150 mg Q12H x 2 doses |
|
|
| D012816 | Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |