Pregabalin on Interleukin-6 Levels in Living Donor Kidney

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ana Ellen de Queiroz Santiago, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01529190
First received: October 3, 2011
Last updated: February 7, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Pregabalin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Preoperative Pregabalin on Pain Intensity and Interleukin-6 Levels in Living Donor Kidney

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Effect of preoperative pregabalin on pain intensity in living donor kidney [ Time Frame: first 24 hours after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of preoperative pregabalin on interleukin-6 levels in living donor kidney [ Time Frame: first 24 hours after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • pregabalin
  • acute pain
  • interleukin-6
Placebo Comparator: sugar pill
group 2 will receive a placebo dose, 1 hour before tue surgical icnision
Drug: Placebo
placebo

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®.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529190

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Rioko K Sakata Federal University of Sao Paulo
  More Information

Publications:
Responsible Party: Ana Ellen de Queiroz Santiago, medical resident, principal investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01529190     History of Changes
Other Study ID Numbers: pregabalin
Study First Received: October 3, 2011
Last Updated: February 7, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
pregabalin
postoperative pain control
interleukin-6
acute pain

Additional relevant MeSH terms:
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014