NCT03482544

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Baskent University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ischemia Reperfusion Injury

Interventions

Type	Name	Description
DRUG	Pragabalin	pregabalin 150 mg will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Pregabalin Group.
OTHER	Placebo	empty capsule will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Control Group.

Timeline

• Start date: 2018-10-10
• Primary completion: 2018-10-30
• Completion: 2018-11-15
• First posted: 2018-03-29
• Last updated: 2018-11-19

Locations

1 site across 1 country: Turkey (Türkiye)