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Lidocaine and Prevention of Chronic Pain

This study is currently recruiting participants.
Verified April 2013 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: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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.

Condition Intervention
Surgery
 Drug: .9 normal saline placebo
Drug: Group L (lidocaine)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Lidocaine to Prevent the Development of Chronic Post-Surgical Pain: a Functional and Morphological Brain Imaging Study

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.
 Drug: .9 normal saline placebo
Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619852

Contacts
Contact: Gildasio DeOliveira, M.D. 312-472-3583 g-jr@northwestern.edu

Locations
United States, Illinois
Prentice Womens' Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Gildasio De Oliveira, M.D.     312-472-3583     g-jr@northwestern.edu    
Contact: Robert J McCarthy, Pharm.D     312-926-9015     r-mccarthy@northwestern.edu    
Principal Investigator: Gildasio De Oliveira, M.D.            
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio De Oliveira, M.D. Northwestern University
  More Information

No publications provided

Responsible Party: Gildasio De Oliveira, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01619852     History of Changes
Other Study ID Numbers: STU00061676
Study First Received: June 12, 2012
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Northwestern University:
Surgery
Breast
Pain
Chronic Pain
 Lidocaine
Anesthesia
Gynecologic
Urologic

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013