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

Phase 4

Completed

• Conditions: Ischemia Reperfusion Injury
• Interventions: Other: Placebo; Drug: Pragabalin

• Registration Number: NCT03482544
• Lead Sponsor: Baskent University

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.

Study Timeline

• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-28
• Study First Posted: 2018-03-29
• Study Start: 2018-10-10
• Primary Completion: 2018-10-30
• Status Verified: 2018-11
• Study Completion: 2018-11-15
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	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.
Pregabalin Group	Pragabalin	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.

Primary Outcome Measures

Name	Time	Method
total oxidant status	before tournique application, just before tournique release, 20 minutes after tournique release	changes of total oxidant status
total antioxidant status	before tournique application, just before tournique release, 20 minutes after tournique release	changes of total antioxidant status
ischemia modified albumin	before tournique application,just before tournique release, 20 minutes after tournique release	changes of ischemia modified albumin

Secondary Outcome Measures

Name	Time	Method
catalase	before tournique application, just before tournique release, 20 minutes after tournique release	changes of catalase

Trial Locations

Locations (1)

Baskent University; 🇹🇷 Konya, Turkey