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

Primary Purpose

Ischemia Reperfusion Injury

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Pragabalin
Placebo
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia Reperfusion Injury focused on measuring pregabalin, ischemia reperfusion injury, muscle

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baskent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pregabalin Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

ischemia modified albumin
changes of ischemia modified albumin
total oxidant status
changes of total oxidant status
total antioxidant status
changes of total antioxidant status

Secondary Outcome Measures

catalase
changes of catalase

Full Information

First Posted
March 5, 2018
Last Updated
November 16, 2018
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT03482544
Brief Title
The Effect of Pregabalin Given Preoperatively on the Tourniquet Induced Ischemia-reperfusion
Official Title
Effect of Orally Pregabalin Given Before Knee Joint Replacement on Reperfusion Injury Which Caused by Bandage
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Reperfusion Injury
Keywords
pregabalin, ischemia reperfusion injury, muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pragabalin
Other Intervention Name(s)
pregabalin 150 mg, Lyrica, Pfezir, Almanya
Intervention Description
pregabalin 150 mg will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Pregabalin Group.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
empty capsule
Intervention Description
empty capsule will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Control Group.
Primary Outcome Measure Information:
Title
ischemia modified albumin
Description
changes of ischemia modified albumin
Time Frame
before tournique application,just before tournique release, 20 minutes after tournique release
Title
total oxidant status
Description
changes of total oxidant status
Time Frame
before tournique application, just before tournique release, 20 minutes after tournique release
Title
total antioxidant status
Description
changes of total antioxidant status
Time Frame
before tournique application, just before tournique release, 20 minutes after tournique release
Secondary Outcome Measure Information:
Title
catalase
Description
changes of catalase
Time Frame
before tournique application, just before tournique release, 20 minutes after tournique release

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Karaca, Assist.Prof
Organizational Affiliation
Baskent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baskent University
City
Konya
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
8528679
Citation
Davies SJ, Reichardt-Pascal SY, Vaughan D, Russell GI. Differential effect of ischaemia-reperfusion injury on anti-oxidant enzyme activity in the rat kidney. Exp Nephrol. 1995 Nov-Dec;3(6):348-54.
Results Reference
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PubMed Identifier
26380243
Citation
Vafapour M, Nematbakhsh M, Monajemi R, Mazaheri S, Talebi A, Talebi N, Shirdavani S. Effect of Gamma-aminobutyric acid on kidney injury induced by renal ischemia-reperfusion in male and female rats: Gender-related difference. Adv Biomed Res. 2015 Jul 27;4:158. doi: 10.4103/2277-9175.161585. eCollection 2015.
Results Reference
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PubMed Identifier
26941907
Citation
Talebi N, Nematbakhsh M, Monajemi R, Mazaheri S, Talebi A, Vafapour M. The Protective Effect of gamma-aminobutyric Acid on Kidney Injury Induced by Renal Ischemia-reperfusion in Ovariectomized Estradiol-treated Rats. Int J Prev Med. 2016 Jan 11;7:6. doi: 10.4103/2008-7802.173796. eCollection 2016.
Results Reference
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The Effect of Pregabalin Given Preoperatively on the Tourniquet Induced Ischemia-reperfusion

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