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Completed

NCT Number: NCT03482544

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

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.

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Key information

Conditions

Ischemia Reperfusion Injury Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baskent University

Konya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pragabalin

Drug

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

Placebo

Other

empty capsule will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Control Group.

Other names: empty capsule

Primary outcomes

  1. ischemia modified albumin

    Time frame: before tournique application,just before tournique release, 20 minutes after tournique release

    changes of ischemia modified albumin

  2. total oxidant status

    Time frame: before tournique application, just before tournique release, 20 minutes after tournique release

    changes of total oxidant status

  3. total antioxidant status

    Time frame: before tournique application, just before tournique release, 20 minutes after tournique release

    changes of total antioxidant status

Secondary outcomes

  1. catalase

    Time frame: before tournique application, just before tournique release, 20 minutes after tournique release

    changes of catalase

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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