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
  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:


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
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: 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: May 7, 2014
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:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014