Persistent Postoperative Pain Incidence With Gabapentin Used (PPP)

H

Hospital Italiano de Buenos Aires

Status and phase

Completed
Phase 4

Conditions

Pain, Postoperative

Treatments

Drug: Gabapentin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02693821
2575

Details and patient eligibility

About

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

Full 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: 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).

Enrollment

122 patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

122 participants in 2 patient groups, including a placebo group

Gabapentin
Experimental group
Description:
300mg of Gabapentin per day (two doses), orally during 30 days
Treatment:
Drug: Gabapentin
Placebo
Placebo Comparator group
Description:
300mg of Placebo per day (two doses), orally during 30 days
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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