Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

Study Overview
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Brief Summary
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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?

Official Title
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A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

Conditions
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Postoperative Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesia physical status class I & II Age ¬< 65 years English-speaking Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- sentinal node biopsy) Exclusion Criteria: Known or suspected allergy, sensitivity, or contraindication to pregabalin Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone Morbid Obesity (Body Mass Index ≥ 45 kg/m2) History of a seizure disorder Pregnancy Current pre-operative therapy with pregabalin, gabapentin, or any opioid Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Lactulose Placebo<br>|
| Experimental: 2<br> | Drug: Pregabalin 150 mg<br>* 150 mg Q12H x 2 doses<br>* Other names: Lyrica;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Pregabalin, Lyrica, Breast surgery