Lidocaine and Prevention of Chronic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01619852
First received: June 12, 2012
Last updated: May 7, 2014
Last verified: May 2014

June 12, 2012
May 7, 2014
June 2012
December 2016   (final data collection date for primary outcome measure)
The development of chronic pain after surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The participants development of chronic pain 6 months after surgery.
Same as current
Complete list of historical versions of study NCT01619852 on ClinicalTrials.gov Archive Site
Brain morphologic and functional changes associated with the development of chronic pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Brain morphologic and functional changes associated with the development of chronic pain at 6 months post surgery.
Same as current
Not Provided
Not Provided
 
Lidocaine and Prevention of Chronic Pain
The Effect of Lidocaine to Prevent the Development of Chronic Post-Surgical Pain: a Functional and Morphological Brain Imaging Study

The study seeks to investigate a safe and inexpensive strategy to reduce persistent post-surgical pain that can affect up to 60% of patients undergoing surgical procedures. It also seeks to investigate specific brain changes associated with the development of chronic pain. This may lead to the development of more specific and more effective treatments.

Hypotheses:

  1. Perioperative systemic lidocaine reduces the incidence of chronic pain in patients undergoing surgical procedures.
  2. There is a specific brain morphological/function change associated with the development of chronic pain.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Surgery
  • Drug: .9 normal saline placebo
    Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.
  • Drug: Group L (lidocaine)
    Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.
  • Active Comparator: Group L
    Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.
    Intervention: Drug: Group L (lidocaine)
  • Placebo Comparator: .9% normal saline placebo
    .9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.
    Intervention: Drug: .9 normal saline placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-64,
  • Females undergoing gynecological, urological or breast surgery

Exclusion Criteria:

  • pregnant,
  • history of chronic use of opioids,
  • allergy to local anesthetics,
  • history of cardiac arrhythmias Drop out: patient or surgeon request
Female
18 Years to 64 Years
No
Contact: Gildasio DeOliveira, M.D. 312-472-3583 g-jr@northwestern.edu
United States
 
NCT01619852
STU00061676
No
Gildasio De Oliveira, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Gildasio De Oliveira, M.D. Northwestern University
Northwestern University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP