Intra-operative Lidocaine Infusion in Preventing CPSP Post VATs

NCT02862769 | Unknown Phase 4

• 1 other identifier: HSREB 107989
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Acute Pain; Neuralgia

Outcome Measures

Primary Outcomes (2)

• Chronic Pain post VATs

  Using the Brief Pain Inventory Scale

  3 months

• Chronic Pain post VATs

  Using the Brief Pain Inventory Scale

  6 months

Secondary Outcomes (4)

• Opioid requirement

  48 hours

• Pain Score for Acute Post Operative Pain

  48 hours post-op

• Mean Pain Scores

  3 and 6 months

• Pain interference

  3 and 6 months

Study Arms (2)

Lidocaine infusion

EXPERIMENTAL

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

Saline Infusion

PLACEBO COMPARATOR

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; Drug: Saline

Interventions

Lidocaine DRUG

. 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.

Lidocaine infusion; Saline Infusion

Saline DRUG

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.

Saline Infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• VATs for lobectomy
• Understanding of English (reading, writing and speaking)
• Written consent for being involved in this study

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (4)

• Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.

  PMID: 26526062 BACKGROUND

• 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.

  PMID: 18632308 RESULT

• 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.

  PMID: 24587187 RESULT

• 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.

  PMID: 23048069 RESULT

MeSH Terms

Conditions

Chronic Pain; Acute Pain; Neuralgia

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Qutaiba Tawfic Hamodi

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qutaiba Tawfic Hamodi

CONTACT

5196466100

Qutaiba Tawfic Hamodi

CONTACT

5196466100; qutaiba.Tawfic@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 11, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)