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Trial record 16 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

Intra-operative Lidocaine Infusion in Preventing CPSP Post VATs

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ClinicalTrials.gov Identifier: NCT02862769
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Qutaiba Tawfic, Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Acute Pain Neuralgia Drug: Lidocaine Drug: Saline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Intra-operative Lidocaine Infusion in Preventing Chronic Post Surgical Pain After Video Assisted Thoracoscopic Surgery
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Lidocaine infusion
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
Drug: Lidocaine
. 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.

Placebo Comparator: Saline 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.
Drug: Lidocaine
. 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.

Drug: Saline
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 Measures :
  1. Chronic Pain post VATs [ Time Frame: 3 months ]
    Using the Brief Pain Inventory Scale

  2. Chronic Pain post VATs [ Time Frame: 6 months ]
    Using the Brief Pain Inventory Scale


Secondary Outcome Measures :
  1. Opioid requirement [ Time Frame: 48 hours ]
    Calculating Opioid dose(1hr, 6hr, 24 hrs and 48 hrs)

  2. Pain Score for Acute Post Operative Pain [ Time Frame: 48 hours post-op ]
    Using Numerical Pain Scale

  3. Mean Pain Scores [ Time Frame: 3 and 6 months ]
  4. Pain interference [ Time Frame: 3 and 6 months ]
    Using the Brief Pain Inventory



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862769


Contacts
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Contact: Qutaiba Tawfic Hamodi 5196466100 ext 61786
Contact: Qutaiba Tawfic Hamodi 5196466100 ext 61786 qutaiba.Tawfic@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: zameer pirani    5198514595    piranizameer@gmail.com   
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Qutaiba Tawfic Hamodi Western University

Publications of Results:
Other Publications:
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Responsible Party: Qutaiba Tawfic, MD, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02862769     History of Changes
Other Study ID Numbers: HSREB 107989
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Neuralgia
Chronic Pain
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Nervous System Diseases
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action