Clinical trial NCT02693821: Persistent Postoperative Pain Incidence With Gabapentin Used
Official title: Persistent Postoperative Pain Incidence With Long Term Perioperative Gabapentin Used
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Gabapentin
prevention
incidence
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 122
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Estudio Controlado, randomizado, prospectivo y ciego.
Primary purpose: PREVENTION

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

Detailed description: 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:

1. 30 days after the surgery. (taking drugs suspended)
2. 3 month after the surgery.
3. 6 months after the surgery.
4. 12 months after the surgery

This monitoring treatment will be done in order to evaluate the presence or absence of persistent postoperative pain (PPP).

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of pain after using gabapentin.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Almagro
country: Argentina
facility: Sofía Konekny
state: Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Francisco FB Bonofiglio, Doctor
role: STUDY_DIRECTOR
References:
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