Pregabalin on Interleukin-6 Levels in Living Donor Kidney

February 7, 2012 updated by: Ana Ellen de Queiroz Santiago, Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pregabalin 300mg
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
Effect of Preoperative Pregabalin on Pain Intensity. 300mg of pregabalin before surgical incision
Other Names:
  • acute pain
  • interleukin-6
Placebo Comparator: sugar pill
group 2 will receive a placebo dose, 1 hour before tue surgical icnision
Drug: Placebo
placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Rioko K Sakata, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Estimate)

February 8, 2012

Last Update Submitted That Met QC Criteria

February 7, 2012

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pregabalin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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