NCT02693821

Persistent Postoperative Pain Incidence With Gabapentin Used

Persistent Postoperative Pain Incidence With Long Term Perioperative Gabapentin Used

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

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).

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Gabapentin	gabapentin 300 mg per day, orally during 30 days
DRUG	Placebo	Placebo 300 mg per day, orally during 30 days

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-01-01
• Completion: 2022-06-01
• First posted: 2016-02-29
• Last updated: 2023-02-06

Locations

1 site across 1 country: Argentina