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Effect of orally given pregabalin before knee joint replacement on incidence of bandage induced reperfusion injury

Effect of pregabalin given preoperatively on the tourniquet induced ischemia-reperfusion injury during total knee arthroplasty surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001207303
Enrollment
54
Registered
2017-08-17
Start date
2017-01-01
Completion date
2017-07-25
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Baskent University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026