Persistent Postoperative Pain Incidence With Gabapentin Used

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Gabapentin; Drug: Placebo

• Registration Number: NCT02693821
• Lead Sponsor: Hospital Italiano de Buenos Aires

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).

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2016-01
• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-02-29
• Study Completion: 2022-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	Gabapentin	300mg of Gabapentin per day (two doses), orally during 30 days
Placebo	Placebo	300mg of Placebo per day (two doses), orally during 30 days

Primary Outcome Measures

Name	Time	Method
Prevalence of pain after using gabapentin.	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.

Trial Locations

Locations (1)

Sofía Konekny; 🇦🇷 Almagro, Buenos Aires, Argentina