Lidocaine and Prevention of Chronic Pain
The Effect of Lidocaine to Prevent the Development of Chronic Post-Surgical Pain
1 other identifier
interventional
148
1 country
1
Brief Summary
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. Hypotheses: Perioperative systemic lidocaine reduces the persistence of chronic pain in patients undergoing surgical procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable surgery
Started Jun 2012
Typical duration for not_applicable surgery
1 active site
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
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
November 27, 2019
CompletedNovember 27, 2019
November 1, 2019
2.1 years
June 12, 2012
January 25, 2016
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Chronic Persistent Pain 3 Months After Surgery as Determined by Character Severity (Yes/no).
The participants development of chronic persistent pain 3 months after surgery as determined by character severity (yes/no).
3 months
Secondary Outcomes (4)
Quality of Recovery
24 hours post operative
Post-surgical Persistent Pain Using Validated Questionnaires (S-LANNS Questionnaire, McGill Questionnaire, Brief Pain Inventory) to Assess Pain Qualities in Accordance With IMMPACT Recommendations.
3 months
Opioid Consumption
24 hours
Postoperative Pain
24 hours
Study Arms (2)
Group L
ACTIVE COMPARATORGroup 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.
.9% normal saline placebo
PLACEBO COMPARATOR.9% normal saline administered as a bolus then as a maintenance infusion for the length of the surgical case.
Interventions
Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.
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.
Eligibility Criteria
You may qualify if:
- Age 18-64,
- Females undergoing gynecological, urological or breast surgery
You may not qualify if:
- pregnant,
- history of chronic use of opioids,
- allergy to local anesthetics,
- history of cardiac arrhythmias Drop out: patient or surgeon request
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prentice Womens' Hospital
Chicago, Illinois, 60611, United States
Related Publications (5)
1) Eric J. Visser. Chronic post-surgical pain: Epidemiology and clinical implications for acute pain management. Acute Pain.2006:8; 73-81
BACKGROUNDPhillips CJ, Harper C. The economics associated with persistent pain. Curr Opin Support Palliat Care. 2011 Jun;5(2):127-30. doi: 10.1097/SPC.0b013e3283458fa9.
PMID: 21430542BACKGROUNDAmr YM, Yousef AA. Evaluation of efficacy of the perioperative administration of Venlafaxine or gabapentin on acute and chronic postmastectomy pain. Clin J Pain. 2010 Jun;26(5):381-5. doi: 10.1097/AJP.0b013e3181cb406e.
PMID: 20473044BACKGROUNDVigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
PMID: 21061107BACKGROUNDAttal N, Gaude V, Brasseur L, Dupuy M, Guirimand F, Parker F, Bouhassira D. Intravenous lidocaine in central pain: a double-blind, placebo-controlled, psychophysical study. Neurology. 2000 Feb 8;54(3):564-74. doi: 10.1212/wnl.54.3.564.
PMID: 10680784BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gildasio De Oliveira, M.D.
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Gildasio De Oliveira, M.D.
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 14, 2012
Study Start
June 1, 2012
Primary Completion
July 1, 2014
Study Completion
January 1, 2015
Last Updated
November 27, 2019
Results First Posted
November 27, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share