NCT03482544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

20 days

First QC Date

March 5, 2018

Last Update Submit

November 16, 2018

Conditions

Ischemia Reperfusion Injury

Keywords

pregabalinischemia reperfusion injurymuscle

Outcome Measures

Primary Outcomes (3)

  • ischemia modified albumin

    changes of ischemia modified albumin

    before tournique application,just before tournique release, 20 minutes after tournique release

  • total oxidant status

    changes of total oxidant status

    before tournique application, just before tournique release, 20 minutes after tournique release

  • total antioxidant status

    changes of total antioxidant status

    before tournique application, just before tournique release, 20 minutes after tournique release

Secondary Outcomes (1)

  • catalase

    before tournique application, just before tournique release, 20 minutes after tournique release

Study Arms (2)

Pregabalin Group

ACTIVE COMPARATOR

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

Control Group

ACTIVE COMPARATOR

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

Interventions

PragabalinDRUG

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

Also known as: pregabalin 150 mg, Lyrica, Pfezir, Almanya
Pregabalin Group
PlaceboOTHER

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

Also known as: empty capsule
Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I-II
  • Undergoing a total knee arthroplasty surgery
  • Accept neuroaxial anesthesia for surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Konya, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 8528679BACKGROUND

  • 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.

    PMID: 26380243BACKGROUND

  • 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.

    PMID: 26941907BACKGROUND

MeSH Terms

Conditions

Reperfusion Injury

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Omer Karaca, Assist.Prof

    Baskent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 29, 2018

Study Start

October 10, 2018

Primary Completion

October 30, 2018

Study Completion

November 15, 2018

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations

TU(1)