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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2018-11-15

Brief Summary

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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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Detailed Description

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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

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Ischemia Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pregabalin Group

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.

Group Type ACTIVE_COMPARATOR

Pragabalin

Intervention Type DRUG

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

Control Group

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.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Pragabalin

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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pregabalin 150 mg, Lyrica, Pfezir, Almanya empty capsule

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes