The Effect of Pregabalin Given Preoperatively on the Tourniquet Induced Ischemia-reperfusion

November 16, 2018 updated by: Omer Karaca, Baskent University

Effect of Orally Pregabalin Given Before Knee Joint Replacement on Reperfusion Injury Which Caused by Bandage

The application of tourniquet is indispensable for a bloodless surgical area in total knee arthroplasty surgery. The release of tourniquet produces reactive oxygen species which can cause injury and then ischemia-reperfusion injury emerge. Our aim in this study is to investigate effects of pregabalin, GABA analog drug, on the tourniquet induced ischemia-reperfusion injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators will randomize patients into two groups. 1) Pregabalin group 2) Control group.

Investigators will give orally pregabalin 150 mg to the pregabalin group patients two times (first dose 1 day before surgery., second dose 1 hour before surgery). On the other hand placebo drug will give to the control group at the same times. Investigators will perform combined spinal epidural anesthesia for surgery and inject 3 cc 0.5% hyperbaric bupivacaine to subarachnoid space. Investigators will take blood samples for measurement of ischemia-reperfusion determinants, immediately before surgery, shortly before tourniquet deflation, and 20 minutes after tourniquet deflation. Then these samples will be analysed by ELISA method.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Başkent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) physical status I-II
  2. Undergoing a total knee arthroplasty surgery
  3. Accept neuroaxial anesthesia for surgery

Exclusion Criteria:

  1. Any antiepileptic drug use
  2. Allergic reaction to pregabalin
  3. Severe hepatic, renal or gastrointestinal disorders
  4. Psychiatric disorders
  5. Pregnant women or breastfeeding
  6. NSAID or opioid drug use for a long time
  7. Diabetic or other neuropathic pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pregabalin Group
We will give 150 mg pregabalin capsule orally 1 day before surgery and 1 hour before surgery (totally two times) to the pregabalin group patients.
Drug: Pragabalin
pregabalin 150 mg will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Pregabalin Group.
Other Names:
  • pregabalin 150 mg, Lyrica, Pfezir, Almanya
Active Comparator: Control Group
In control group, we will empty the drug material from capsules and give only empty capsules to the control group patients at the same times.
Other: Placebo
empty capsule will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Control Group.
Other Names:
  • empty capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischemia modified albumin
Time Frame: before tournique application,just before tournique release, 20 minutes after tournique release
changes of ischemia modified albumin
before tournique application,just before tournique release, 20 minutes after tournique release
total oxidant status
Time Frame: before tournique application, just before tournique release, 20 minutes after tournique release
changes of total oxidant status
before tournique application, just before tournique release, 20 minutes after tournique release
total antioxidant status
Time Frame: before tournique application, just before tournique release, 20 minutes after tournique release
changes of total antioxidant status
before tournique application, just before tournique release, 20 minutes after tournique release

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
catalase
Time Frame: before tournique application, just before tournique release, 20 minutes after tournique release
changes of catalase
before tournique application, just before tournique release, 20 minutes after tournique release

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

  • Principal Investigator: Omer Karaca, Assist.Prof, Başkent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

November 15, 2018

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA16/10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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