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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482544
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Omer Karaca, 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.

Condition or disease Intervention/treatment Phase
Ischemia Reperfusion Injury Drug: Pragabalin Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Orally Pregabalin Given Before Knee Joint Replacement on Reperfusion Injury Which Caused by Bandage
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: 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.
Drug: Pragabalin
pregabalin 150 mg will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Pregabalin Group.
Other Name: pregabalin 150 mg, Lyrica, Pfezir, Almanya

Active Comparator: 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.
Other: Placebo
empty capsule will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Control Group.
Other Name: empty capsule




Primary Outcome Measures :
  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 Outcome Measures :
  1. catalase [ Time Frame: before tournique application, just before tournique release, 20 minutes after tournique release ]
    changes of catalase



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482544


Locations
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Turkey
Baskent University
Konya, Turkey
Sponsors and Collaborators
Baskent University
Investigators
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Principal Investigator: Omer Karaca, Assist.Prof Baskent University

Publications:
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Responsible Party: Omer Karaca, Assistant Professor, Baskent University
ClinicalTrials.gov Identifier: NCT03482544    
Other Study ID Numbers: KA16/10
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Omer Karaca, Baskent University:
pregabalin
ischemia reperfusion injury
muscle
Additional relevant MeSH terms:
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Reperfusion Injury
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs