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Persistent Postoperative Pain Incidence With Gabapentin Used (PPP)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Gabapentin, prevention, incidence

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Sofía Konekny

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gabapentin

Placebo

Arm Description

300mg of Gabapentin per day (two doses), orally during 30 days

300mg of Placebo per day (two doses), orally during 30 days

Outcomes

Primary Outcome Measures

Prevalence of pain after using gabapentin.
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.

Secondary Outcome Measures

Full Information

First Posted
February 19, 2016
Last Updated
February 2, 2023
Sponsor
Hospital Italiano de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT02693821
Brief Title
Persistent Postoperative Pain Incidence With Gabapentin Used
Acronym
PPP
Official Title
Persistent Postoperative Pain Incidence With Long Term Perioperative Gabapentin Used
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Gabapentin, prevention, incidence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Estudio Controlado, randomizado, prospectivo y ciego.
Masking
ParticipantInvestigator
Masking Description
Cuando el paciente dé su consentimiento, será reclutado y randomizado a un grupo control (recibirá placebo) o a un grupo tratamiento (recibirá gabapentin) Los pacientes recibirán una técnica anestésica habitual, basadas en drogas endovenosas mediante el método TCI (target controlled infusión). Con este método se unifica el uso de las drogas anestésicas, que son utilizadas de acuerdo a sexo, edad, género, peso y altura en cada uno de los pacientes. La analgesia será la convencional para cada cirugía y se continuará con el uso de catéteres epidurales, para analgesia en aquellas intervenciones donde su aplicación sea habitual.
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
300mg of Gabapentin per day (two doses), orally during 30 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
300mg of Placebo per day (two doses), orally during 30 days
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
gabapentin 300 mg per day, orally during 30 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 300 mg per day, orally during 30 days
Primary Outcome Measure Information:
Title
Prevalence of pain after using gabapentin.
Description
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.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco FB Bonofiglio, Doctor
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Study Director
Facility Information:
Facility Name
Sofía Konekny
City
Almagro
State/Province
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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16698416
Citation
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Persistent Postoperative Pain Incidence With Gabapentin Used

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