NCT01529190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 pain

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
Last Updated

February 8, 2012

Status Verified

December 1, 2011

Enrollment Period

9 months

First QC Date

October 3, 2011

Last Update Submit

February 7, 2012

Conditions

Pain

Keywords

pregabalinpostoperative pain controlinterleukin-6acute pain

Outcome Measures

Primary Outcomes (1)

  • Effect of preoperative pregabalin on pain intensity in living donor kidney

    first 24 hours after surgery

Secondary Outcomes (1)

  • Effect of preoperative pregabalin on interleukin-6 levels in living donor kidney

    first 24 hours after surgery

Study Arms (2)

pregabalin 300mg

ACTIVE COMPARATOR

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

sugar pill

PLACEBO COMPARATOR

group 2 will receive a placebo dose, 1 hour before tue surgical icnision

Drug: Placebo

Interventions

PregabalinDRUG

Effect of Preoperative Pregabalin on Pain Intensity. 300mg of pregabalin before surgical incision

Also known as: acute pain, interleukin-6
pregabalin 300mg
PlaceboDRUG

placebo

sugar pill

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • living donor kidney

You may not qualify if:

  • myocardial ischemia
  • psychiatric disease
  • absence of chronic pain
  • absence of drugs dependency
  • don´t use of opioid medication 1 week before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (3)

  • Taylor CP. Mechanisms of analgesia by gabapentin and pregabalin--calcium channel alpha2-delta [Cavalpha2-delta] ligands. Pain. 2009 Mar;142(1-2):13-6. doi: 10.1016/j.pain.2008.11.019. Epub 2009 Jan 6. No abstract available.

    PMID: 19128880BACKGROUND

  • Gray P, Kirby J, Smith MT, Cabot PJ, Williams B, Doecke J, Cramond T. Pregabalin in severe burn injury pain: a double-blind, randomised placebo-controlled trial. Pain. 2011 Jun;152(6):1279-1288. doi: 10.1016/j.pain.2011.01.055. Epub 2011 Mar 12.

    PMID: 21398038BACKGROUND

  • Baidya DK, Agarwal A, Khanna P, Arora MK. Pregabalin in acute and chronic pain. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):307-14. doi: 10.4103/0970-9185.83672.

    PMID: 21897498BACKGROUND

MeSH Terms

Conditions

PainAcute Pain

Interventions

PregabalinPain ClinicsInterleukin-6

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsOutpatient Clinics, HospitalAmbulatory Care FacilitiesHealth FacilitiesHealth Care Facilities Workforce and ServicesHospital DepartmentsHospital AdministrationHealth Facility AdministrationOrganization and AdministrationHealth Services AdministrationInterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesProteinsBiological Factors

Study Officials

  • Rioko K Sakata

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical resident, principal investigator

Study Record Dates

First Submitted

October 3, 2011

First Posted

February 8, 2012

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 8, 2012

Record last verified: 2011-12

Locations

BR(1)