Pregabalin on Interleukin-6 Levels in Living Donor Kidney

Study Overview
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Brief Summary
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Pregabalin, a ligand for alfa2delta subunits of voltage-gated calcium channels, has been shown to be an effective adjuvant therapy for acute postoperative pain, by inhibiting central sensitization. The IL-6, is detectable 60 minutes after surgical incision, persisting for until 10 days, with maximal plasmatic level in 4 and 6 hours. The objective of this study is evaluating the analgesic effect of pregabalin and its repercussion on serum levels of IL6.

Detailed Description
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After approved by the Ethical Committee and signed informed consent, 40 patients aged from 18 until 60 years undergoing nephrectomy will be randomized in two groups. Group 1 patients will receive a single dose of 300 mg pregabalin, 1 hour before the surgical incision; group 2 patients will receive a placebo dose. Pain intensity will be assessed with the numeric rating scale. The consumption of tramadol in 24 hours after surgery and the time for the first complementation dose will be registered. Blood samples will be collected by 6 hours and 24 hours after surgical incision, for IL-6 dosage, and maintained at -70 celsus degree. The IL-6 dosages will be performed by the ELISA (enzyme-linked immunosorbent assay) method. The number of patients was calculated by Instat Graph® program. To detect difference in pain intensity of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 20. Statistical analyses will be performed with parametric and nonparametric tests, considering the variety studied. The statistical program that will be utilized is Instat Graph®.

Official Title
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Effect of Preoperative Pregabalin on Pain Intensity and Interleukin-6 Levels in Living Donor Kidney

Conditions
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Pain

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: living donor kidney Exclusion Criteria: myocardial ischemia psychiatric disease absence of chronic pain absence of drugs dependency don´t use of opioid medication 1 week before surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pregabalin 300mg<br>Group 1 patients will receive a single dose of 300 mg pregabalin, 1 hour before the surgical incision; group 2 patients will receive a placebo dose. Pain intensity will be assessed with the numeric rating scale. The consumption of tramadol in 24 hours after surgery and the time for the first complementation dose will be registered. Blood samples will be collected by 6 hours and 24 hours after surgical incision, for IL-6 dosage, and maintained at -70 celsus degree | Drug: Pregabalin<br>* Effect of Preoperative Pregabalin on Pain Intensity. 300mg of pregabalin before surgical incision<br>* Other names: interleukin-6;|
| Placebo Comparator: sugar pill<br>group 2 will receive a placebo dose, 1 hour before tue surgical icnision | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of preoperative pregabalin on pain intensity in living donor kidney |  | first 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of preoperative pregabalin on interleukin-6 levels in living donor kidney |  | first 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregabalin, postoperative pain control, interleukin-6, acute pain