Skip to main content
OpenTrials
Completed

NCT Number: NCT02693821

Persistent Postoperative Pain Incidence With Gabapentin Used

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sofía Konekny

Almagro, Buenos Aires, C1199ABB, Argentina

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

gabapentin 300 mg per day, orally during 30 days

Placebo

Drug

Placebo 300 mg per day, orally during 30 days

Primary outcomes

  1. Prevalence of pain after using gabapentin.

    Time frame: Two years

    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.

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

Persistent Postoperative Pain Incidence With Long Term Perioperative Gabapentin Used

Acronym: PPP

Important dates

Study start
2015
Primary completion
2016
Study completion
2022
First posted
Feb 29, 2016
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.