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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03482544

Enrollment

Registered

2018-03-29

Start date

2018-10-10

Completion date

2018-11-15

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia Reperfusion Injury

Keywords

pregabalin, ischemia reperfusion injury, muscle

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.

Interventions

DRUGPragabalin

pregabalin 150 mg will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Pregabalin Group.

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
ischemia modified albumin	before tournique application,just before tournique release, 20 minutes after tournique release	changes of ischemia modified albumin
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

Secondary

Measure	Time frame	Description
catalase	before tournique application, just before tournique release, 20 minutes after tournique release	changes of catalase

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026