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

• Sponsor: Baskent University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03482544
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.2
• Patients Per Site Per Month: 45.7

Study Details

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.

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.

Study Design

• Study Type: Interventional
• 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: Oct 10, 2018
• Actual Primary Completion Date: Oct 30, 2018
• Actual Study Completion Date: Nov 15, 2018

Arms and Interventions

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 Names: 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 Names: empty capsule

Outcome Measures

Primary Outcome Measures

1. ischemia modified albumin [before tournique application,just before tournique release, 20 minutes after tournique release]

   changes of ischemia modified albumin

2. total oxidant status [before tournique application, just before tournique release, 20 minutes after tournique release]

   changes of total oxidant status

3. total antioxidant status [before tournique application, just before tournique release, 20 minutes after tournique release]

   changes of total antioxidant status

Secondary Outcome Measures

1. catalase [before tournique application, just before tournique release, 20 minutes after tournique release]

   changes of catalase

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baskent University	Konya		Turkey

Sponsors and Collaborators

• Baskent University

Investigators

• Principal Investigator: Omer Karaca, Assist.Prof, Baskent University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Talebi N, Nematbakhsh M, Monajemi R, Mazaheri S, Talebi A, Vafapour M. The Protective Effect of γ-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.
• Vafapour M, Nematbakhsh M, Monajemi R, Mazaheri S, Talebi A, Talebi N, Shirdavani S. Effect of Γ-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.

• Responsible Party: Omer Karaca, Assistant Professor, Baskent University
• ClinicalTrials.gov Identifier: NCT03482544
• Other Study ID Numbers: KA16/10
• First Posted: Mar 29, 2018
• Last Update Posted: Nov 19, 2018
• Last Verified: Nov 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Omer Karaca, Assistant Professor, Baskent University: pregabalin; ischemia reperfusion injury; muscle
• Additional relevant MeSH terms: Reperfusion Injury; Ischemia; Pregabalin

Study Results

No Results Posted as of Nov 19, 2018