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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Ischemia Reperfusion Injury

Intervention / Treatment
-----------------
* Drug: Pragabalin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-II Undergoing a total knee arthroplasty surgery Accept neuroaxial anesthesia for surgery Exclusion Criteria: Any antiepileptic drug use Allergic reaction to pregabalin Severe hepatic, renal or gastrointestinal disorders Psychiatric disorders Pregnant women or breastfeeding NSAID or opioid drug use for a long time Diabetic or other neuropathic pain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pregabalin Group<br>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<br>* pregabalin 150 mg will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Pregabalin Group.<br>* Other names: pregabalin 150 mg, Lyrica, Pfezir, Almanya;|
| Active Comparator: Control Group<br>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<br>* empty capsule will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Control Group.<br>* Other names: empty capsule;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregabalin, ischemia reperfusion injury, muscle