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

Ischemia Reperfusion Injury Clinical Trial

Official title:

Effect of Orally Pregabalin Given Before Knee Joint Replacement on Reperfusion Injury Which Caused by Bandage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482544
• Other study ID #: KA16/10
• Status: Completed
• Phase: Phase 4
• Start date: October 10, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: November 2018
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 15, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemia Reperfusion Injury
• Reperfusion Injury

Intervention

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

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

Locations

Country	Name	City	State
Turkey	Baskent University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Talebi N, Nematbakhsh M, Monajemi R, Mazaheri S, Talebi A, Vafapour M. The Protective Effect of ?-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. — View Citation

Vafapour M, Nematbakhsh M, Monajemi R, Mazaheri S, Talebi A, Talebi N, Shirdavani S. Effect of G-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ischemia modified albumin	changes of ischemia modified albumin	before tournique application,just before tournique release, 20 minutes after tournique release
Primary	total oxidant status	changes of total oxidant status	before tournique application, just before tournique release, 20 minutes after tournique release
Primary	total antioxidant status	changes of total antioxidant status	before tournique application, just before tournique release, 20 minutes after tournique release
Secondary	catalase	changes of catalase	before tournique application, just before tournique release, 20 minutes after tournique release