Pregabalin on Interleukin-6 Levels in Living Donor Kidney

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT01529190
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

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®.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-10-03
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted QC: 2012-02-07
• Last Update Submitted: 2012-02-07
• Study First Posted: 2012-02-08
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	Placebo	group 2 will receive a placebo dose, 1 hour before tue surgical icnision
pregabalin 300mg	Pregabalin	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

Primary Outcome Measures

Name	Time	Method
Effect of preoperative pregabalin on pain intensity in living donor kidney	first 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Effect of preoperative pregabalin on interleukin-6 levels in living donor kidney	first 24 hours after surgery

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil