Persistent Postoperative Pain Incidence With Gabapentin Used

Study Overview
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Brief Summary
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The study's objective will be to evaluate the gabapentine efficiency in orally and long term used after painfully surgeries.

Detailed Description
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This study will be: controlled, prospective, randomized and double blind. Its main objective will be to evaluate the pre and postoperative Gabapentin efficiency in orally doses and long term used of it in order to prevent or decrease persistent postoperative pain (PPP) in surgeries with high incidence of it (Pain). Patients will be randomly divided in two branches; one of them will take 600 mg of Gabapentin twice a day and the other group will take Placebo (twice a day also). Both groups of patients will have to take one pill the day before the surgery (300 mg) and other pill on the surgery day (300mg). After that, the patients will have to continue this treatment during 30 days (two doses per day of Gabapentin or placebo). After the surgery and after taking the second pill, it will be evaluated: postoperative sharp pain, sickness, vomiting, sedation and adverse effects. Patients will be evaluated in the pain treatment office (consulting room) the following times: 30 days after the surgery. (taking drugs suspended) 3 month after the surgery. 6 months after the surgery. 12 months after the surgery This monitoring treatment will be done in order to evaluate the presence or absence of persistent postoperative pain (PPP).

Official Title
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Persistent Postoperative Pain Incidence With Long Term Perioperative Gabapentin Used

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that require persistent painfully surgeries such as breast surgeries (mastectomies and breast implants), herniorrhaphies (not laparoscopical) unilateral or bilateral, amputations of upper and lower limbs and chest surgeries (thoracotomy, thoracoscopy , sternotomies). Patients that had already signed the informed consent. Patients aged between 21 and 75. ASA I - II _ III (Classification system that the American Society of Anesthesiologists (ASA) uses to estimate the anesthesiology risk that patients may suffer) BMI, not more than 35 Kg/m2. Exclusion Criteria: Pregnant women Patients that suffer liver and renal failure (plasma creatinine over 1.5 mg/ml or creatinine clearance less than 60 ml/min),heart failure or neurological dysfunction. Diabetic patients Gabapentine allergic patients

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Estudio Controlado, randomizado, prospectivo y ciego.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>300mg of Gabapentin per day (two doses), orally during 30 days | Drug: Gabapentin<br>* gabapentin 300 mg per day, orally during 30 days<br>|
| Placebo Comparator: Placebo<br>300mg of Placebo per day (two doses), orally during 30 days | Drug: Placebo<br>* Placebo 300 mg per day, orally during 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pain after using gabapentin. | It will be used a 10cm ruler which will allows the patients indicates how much pain they are feeling at the moment, where 0 is no pain at all and 10 is the maximum imaginable pain. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gabapentin, prevention, incidence