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Intra-operative Lidocaine Infusion in Preventing CPSP Post VATs

Primary Purpose

Chronic Pain, Acute Pain, Neuralgia

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine
Saline
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • VATs for lobectomy
  • Understanding of English (reading, writing and speaking)
  • Written consent for being involved in this study
  • Exclusion Criteria:
  • Chronic pain including fibromyalgia
  • Patients using opioids (more than 80 mg equivalent of oral morphine/day for >60 days)
  • Major depression
  • Received or going to receive chemotherapy or radiotherapy.
  • Pregnant

Sites / Locations

  • London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine infusion

Saline Infusion

Arm Description

first group (lidocaine group) will include those who receive a intraoperative lidocaine infusion (Induction bolus dose of 1.5 mg/kg body weight followed by a continous lidocaine infusion

The second group will include those who receive a intraoperative placebo i(Induction bolus dose of 1.5 mg/kg body weight of lidocaine followed by a continous saline infusion at the same rate as the lidocaine infusion.

Outcomes

Primary Outcome Measures

Chronic Pain post VATs
Using the Brief Pain Inventory Scale
Chronic Pain post VATs
Using the Brief Pain Inventory Scale

Secondary Outcome Measures

Opioid requirement
Calculating Opioid dose(1hr, 6hr, 24 hrs and 48 hrs)
Pain Score for Acute Post Operative Pain
Using Numerical Pain Scale
Mean Pain Scores
Pain interference
Using the Brief Pain Inventory

Full Information

First Posted
July 28, 2016
Last Updated
October 22, 2018
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02862769
Brief Title
Intra-operative Lidocaine Infusion in Preventing CPSP Post VATs
Official Title
The Role of Intra-operative Lidocaine Infusion in Preventing Chronic Post Surgical Pain After Video Assisted Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the impact of intravenous lidocaine on acute and chronic post surgical pain on patients undergoing video assisted thoracoscopic surgery(VATS). The investigators believe that systemic administration of lidocaine during the perioperative period would be effective in preventing chronic pain post VATS. In addition to chronic pain the investigators believe it will reduce acute postoperative pain as well as each patients total opioid requirement.The investigators believe that this will have a significant impact on the care of patients presenting for VATS.
Detailed Description
It is not surprising that complications related to surgical procedures occur. Chronic Post Surgical Pain (CPSP) is considered one of the more common surgical complications, despite all the advances in understanding acute pain and the development of new modalities for pain management 1. Chronic Post Surgical Pain was defined by Macrae and Davies 7 as a persistent pain, which existed for a minimum of two months following a surgical procedure. The condition of pre-existence of pain, and causes for the pain other than surgery should be excluded. Thoracic surgeries including thoracotomy and video-assisted thoracoscopic surgery (VATS) are some of the highest risk procedures that often lead to CPSP. The prevalence of chronic pain after VATS is close to that after thoracotomy (25-47 %), half of them having neuropathic pain A, B. Because of the fact that chronic pain is a major physical and mental health care problem affecting the patient and the community in general, it has become essential for physicians to prevent the development of chronic pain 8. While multimodal analgesia has largely replaced pain mono-therapy with opioids, they remain the most commonly used medications to treat post operative pain. Lidocaine is an amide local anesthetic which when used intravenously demonstrates significant analgesic, anti-hyperalgesic and anti-inflammatory properties . It also reduces the sensitivity and activity of spinal cord neurons, decreases N-methyl-D-aspartate (NMDA) receptors mediated post-synaptic depolarization. The analgesic effects of systemic lidocaine were first tested in chronic neuropathic pain when the results support the usage of these drugs. Perioperatively, when lidocaine is administered as a continuous infusion at clinically relevant doses (1-2 mg/kg/hr) results in plasma concentration below 5µg.mL-1. At this plasma level, it is adequate to attenuate sympathetic responses , decrease pain and demonstrate a significant opioid sparing effect. Perioperative lidocaine administration was associated with a decreased incidence of CPSP when it is associated with neuropathic pain . It reduced CPSP in mastectomy by 40-50% after 3 and 6 months follow-up. To the best of our knowledge there is no study that has addressed the usage of lidocaine in VATS or thoracotomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Acute Pain, Neuralgia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine infusion
Arm Type
Experimental
Arm Description
first group (lidocaine group) will include those who receive a intraoperative lidocaine infusion (Induction bolus dose of 1.5 mg/kg body weight followed by a continous lidocaine infusion
Arm Title
Saline Infusion
Arm Type
Placebo Comparator
Arm Description
The second group will include those who receive a intraoperative placebo i(Induction bolus dose of 1.5 mg/kg body weight of lidocaine followed by a continous saline infusion at the same rate as the lidocaine infusion.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
. Perioperatively, when lidocaine is administered as a continuous infusion at clinically relevant doses (1-2 mg/kg/hr) results in plasma concentration below 5µg.mL-1. At this plasma level, it is adequate to attenuate sympathetic responses , decrease pain and demonstrate a significant opioid sparing effect.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
The second group will include those who receive a intraoperative placebo infusion(saline infusion) (Induction bolus dose of 1.5 mg/kg body weight followed by a continous saline infusion 1.5 mg/kg/hr.
Primary Outcome Measure Information:
Title
Chronic Pain post VATs
Description
Using the Brief Pain Inventory Scale
Time Frame
3 months
Title
Chronic Pain post VATs
Description
Using the Brief Pain Inventory Scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Opioid requirement
Description
Calculating Opioid dose(1hr, 6hr, 24 hrs and 48 hrs)
Time Frame
48 hours
Title
Pain Score for Acute Post Operative Pain
Description
Using Numerical Pain Scale
Time Frame
48 hours post-op
Title
Mean Pain Scores
Time Frame
3 and 6 months
Title
Pain interference
Description
Using the Brief Pain Inventory
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: VATs for lobectomy Understanding of English (reading, writing and speaking) Written consent for being involved in this study Exclusion Criteria: Chronic pain including fibromyalgia Patients using opioids (more than 80 mg equivalent of oral morphine/day for >60 days) Major depression Received or going to receive chemotherapy or radiotherapy. Pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qutaiba Tawfic Hamodi
Phone
5196466100
Ext
61786
First Name & Middle Initial & Last Name or Official Title & Degree
Qutaiba Tawfic Hamodi
Phone
5196466100
Ext
61786
Email
qutaiba.Tawfic@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qutaiba Tawfic Hamodi
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zameer pirani
Phone
5198514595
Email
piranizameer@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26526062
Citation
Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
Results Reference
background
PubMed Identifier
18632308
Citation
Steegers MA, Snik DM, Verhagen AF, van der Drift MA, Wilder-Smith OH. Only half of the chronic pain after thoracic surgery shows a neuropathic component. J Pain. 2008 Oct;9(10):955-61. doi: 10.1016/j.jpain.2008.05.009. Epub 2008 Jul 16.
Results Reference
result
PubMed Identifier
24587187
Citation
Peng Z, Li H, Zhang C, Qian X, Feng Z, Zhu S. A retrospective study of chronic post-surgical pain following thoracic surgery: prevalence, risk factors, incidence of neuropathic component, and impact on qualify of life. PLoS One. 2014 Feb 28;9(2):e90014. doi: 10.1371/journal.pone.0090014. eCollection 2014.
Results Reference
result
PubMed Identifier
23048069
Citation
Usichenko TI, Rottenbacher I, Kohlmann T, Julich A, Lange J, Mustea A, Engel G, Wendt M. Implementation of the quality management system improves postoperative pain treatment: a prospective pre-/post-interventional questionnaire study. Br J Anaesth. 2013 Jan;110(1):87-95. doi: 10.1093/bja/aes352. Epub 2012 Oct 9.
Results Reference
result

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Intra-operative Lidocaine Infusion in Preventing CPSP Post VATs

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