Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001207303
Ethics application status
Approved
Date submitted
31/07/2017
Date registered
17/08/2017
Date last updated
17/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of orally given pregabalin before knee joint replacement on incidence of bandage induced reperfusion injury
Scientific title
Effect of pregabalin given preoperatively on the tourniquet induced ischemia-reperfusion injury during total knee arthroplasty surgery
Secondary ID [1] 292559 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee arhroplasty 304218 0
ischemia-reperfusion injury 304348 0
Condition category
Condition code
Anaesthesiology 303567 303567 0 0
Other anaesthesiology
Musculoskeletal 303568 303568 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will divide in two groups. We will give 150 mg pregabalin capsule orally 1 day before surgery and 1 hour before surgery (totally two times) to pregabalin group patients. In control group, we will empty the drug material from capsules and give only empty capsules to control group patients at the same times.
Intervention code [1] 298760 0
Treatment: Drugs
Comparator / control treatment
In control group, we will empty the drug material from capsules and give only empty capsules to control group patients at the same times.
Control group
Placebo

Outcomes
Primary outcome [1] 302928 0
Determination effect of pregabalin on tourniquet induced ischemia reperfusion injury. For this purpose we will measure catalase, ischemic modified albumin, total antioxidant status, total oxidant status in blood samples.
Timepoint [1] 302928 0
we have three timepoints for measurements: Immediately before surgery, 5 minutes before tourniquet deflation, 20 minutes later tourniquet deflation
Secondary outcome [1] 337501 0
Patient's anxiety levels will be evaluated. We will use visual analog scale for anxiety levels.
Timepoint [1] 337501 0
We have three timepoints for secondary outcome: 1 day before surgery just before given pregabalin first dose, just before second pregabalin dose, before patients go into operation room.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
25/07/2017
Date of last data collection
Anticipated
Actual
25/07/2017
Sample size
Target
54
Accrual to date
Final
54
Recruitment outside Australia
Country [1] 9115 0
Turkey
State/province [1] 9115 0
Konya

Funding & Sponsors
Funding source category [1] 297137 0
University
Name [1] 297137 0
Baskent University
Country [1] 297137 0
Turkey
Primary sponsor type
University
Name
Baskent University
Address
Taskent Caddesi (Eski 1. Cadde) 77. Sokak (Eski 16. Sokak) No:11 06490 Bahcelievler / ANKARA
Country
Turkey
Secondary sponsor category [1] 296152 0
None
Name [1] 296152 0
Address [1] 296152 0
Country [1] 296152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298306 0
Baskent University Clinical Research Ethical Committee
Ethics committee address [1] 298306 0
Taskent Caddesi 77. Sokak No:11 06490 Bahcelievler Cankaya Ankara
Ethics committee country [1] 298306 0
Turkey
Date submitted for ethics approval [1] 298306 0
Approval date [1] 298306 0
23/12/2016
Ethics approval number [1] 298306 0
KA 16/10

Summary
Brief summary
Extremity surgeries require tourniquet for a bloodless surgical area. But, tourniquet applications cause ischemia-reperfusion injury. Our aim in this study is to investigate effect of preoperatively given pregabalin, GABA analog drug, on the tourniquet induced ischemia-reperfusion injury.
54 patients between 18-65 years who undergo total knee arthroplasty participate the study. Criteria for inclusion are patients whom American Society of Anesthesiologists (ASA) physical status I-II, undergoing a total knee arthroplasty surgery, accept neuroaxial anesthesia for surgery. Criteria for exclusion are patients who use any antiepileptic drug, allergic reaction to pregabalin, severe hepatic, renal or gastrointestinal disorders, physciatric disorders, pregnants or breastfeeding, NSAID or opioid drug use for a long time, diabetic or other neuropathic pain.
We randomize patients into two groups. 1) Pregabalin group 2) Control group
We give pregabalin 150 mg orally to pregabalin group patients two times (first dose 1 day before surgery., second dose 1 hour before surgery). We give placebo drug at the same times to the control group. We perform combined spinal epidural anesthesia for surgery. we give 3 cc 0.5% hyperbaric bupivacaine for spinal anesthesia. We take blood samples for measurement of ischemia-reperfusion determinants, immediately before surgery, 5 minutes before tourniquet deflation, and 20 minutes after tourniquet deflation.
We compare these results with appropriate statistical methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76662 0
Mr Huseyin Ulas Pinar
Address 76662 0
Baskent University Konya Research Center,Hocacihan mah. saray cad No:1 Selcuklu/ Konya Postal Code: 42080
Country 76662 0
Turkey
Phone 76662 0
+903322570606
Fax 76662 0
Email 76662 0
[email protected]
Contact person for public queries
Name 76663 0
Mr Huseyin Ulas Pinar
Address 76663 0
Baskent University Konya Research Center, Hocacihan mah. saray cad No:1 Selcuklu/ Konya Postal Code: 42080
Country 76663 0
Turkey
Phone 76663 0
+903322570606
Fax 76663 0
Email 76663 0
[email protected]
Contact person for scientific queries
Name 76664 0
Mr Huseyin Ulas Pinar
Address 76664 0
Baskent University Konya Research Center, Hocacihan mah. saray cad No:1 Selcuklu/ Konya Postal Code: 42080
Country 76664 0
Turkey
Phone 76664 0
+903322570606
Fax 76664 0
Email 76664 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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