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Intravenous Lidocaine Infusion During Video-assisted Thoracic Procedures for Improved Pain Control

This study is currently recruiting participants.
Verified February 2013 by University of Saskatchewan
Sponsor:
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01277835
First received: April 9, 2010
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to determine whether intravenous lidocaine infusion during a video-assisted chest surgery is effective in reducing the pain involved after the surgery. The hypothesis is that continuous lidocaine infusion during video-assisted thoracoscopic surgery (VATS) reduces morphine consumption and postoperative pain.


Condition Intervention
Pain
 Drug: Lidocaine Infusion
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Lidocaine Infusion During VATS Procedures Reduces Postoperative Analgesic Requirements

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Verbal Rating Scale for pain with deep inspiration [ Time Frame: Up to 48 hrs post-initiation of patient-controlled analgesia ] [ Designated as safety issue: No ]
    Patients will be questioned about pain intensities with a deep inspiratory breath using the Verbal Rating Scale (0-10) at 8, 16, 24, 36, and 48 hours post-initiaition of patient-controlled analgesia.

  • PCA Morphine Consumption [ Time Frame: Up to 48hrs post-initiation of patient-controlled analgesia ] [ Designated as safety issue: No ]
    Patient-controlled analgesia machines will be reviewed for the total morphine doses administered at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.

  • Number of PCA Morphine Requests [ Time Frame: Up to 48hrs post-initiation of patient-controlled analgesia ] [ Designated as safety issue: No ]
    PCA machines will be reviewed for total number of PCA requests at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.

  • Verbal Rating Scale for pain at rest [ Time Frame: Up to 48hrs post-initiation of patient-controlled analgesia ] [ Designated as safety issue: No ]
    Patients will be questioned about pain intensities at rest using the Verbal Rating Scale (0-10) at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.


Secondary Outcome Measures:
  • Nausea [ Time Frame: Up to 48hrs post-initiation of patient-controlled analgesia ] [ Designated as safety issue: No ]
    Patients will be questioned about the side effect of nausea at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.

  • Vomiting [ Time Frame: Up to 48hrs post-initiation of patient-controlled analgesia ] [ Designated as safety issue: No ]
    Patients will be questioned about the side effect of vomiting at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.

  • Pruritus [ Time Frame: Up to 48hrs post-initiation of patient-controlled analgesia ] [ Designated as safety issue: No ]
    Patients will be questioned about the side effect of pruritus at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.

  • Constipation [ Time Frame: Up to 48hrs post-initiation of patient-controlled analgesia ] [ Designated as safety issue: No ]
    Patients will be questioned about the side effect of constipation at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.

  • Urinary Retention [ Time Frame: Up to 48hrs post-initiation of patient-controlled analgesia ] [ Designated as safety issue: No ]
    Patients will be questioned about the side effect of urinary retention at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.


Estimated Enrollment: 80
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine Infusion Drug: Lidocaine Infusion
Infusion of lidocaine 3mg/min or 2mg/min during surgery
Placebo Comparator: Placebo
Saline Infusion
 Drug: Placebo
Saline Infusion at same rate as experimental arm

Detailed Description:

Despite newer surgical techniques, many patients still experience moderate to severe postoperative pain after minimally invasive surgeries. Thoracoscopic surgeries are often associated with severe postoperative pain. To relieve the pain, potent narcotics have to be used, which have many side effects. Surgical patients would therefore benefit from an intra-operative analgesic regimen that is safe and effective, has minimal side effects and can reduce their postoperative narcotic requirements. Intravenous lidocaine has been shown previously to relieve cancer pain, chronic pain, and pain after other types of surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III
  • Age 18-75
  • Scheduled for VATS procedure

Exclusion Criteria:

  • Patients receiving antiarrhythmic therapy (Class Ia, Ib, Ic) within one week of surgery
  • Patients on preoperative analgesic therapy within one week of surgery
  • Patients with history of drug or alcohol abuse
  • Patients who are allergic to lidocaine
  • Contraindication to self administered morphine (unable to understand the PCA)
  • Progression of the procedure to thoracotomy
  • Patients who need postoperative mechanical ventilation
  • Necessary major deviation from the intraoperative study protocol as per the discretion of the anesthesiologist in charge of the case
  • Patients who are breastfeeding or pregnant
  • Patient refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277835

Contacts
Contact: Jennifer O'Brien 655-6497 jennifer.obrien@saskatoonhealthregion.ca
Contact: Brian Taylor, MD 655-1000 bgt773@mail.usask.ca

Locations
Canada, Saskatchewan
St. Paul's Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Contact: Dennis Ong, MD FRCPC     655-1183     Dennis.Ong@saskatoonhealthregion.ca    
Contact: Brian Taylor, MD     655-1000     bgt773@mail.usask.ca    
Principal Investigator: Dennis Ong, MD FRCPC            
Sub-Investigator: Brian Taylor, MD            
Sub-Investigator: Ashraf Salem, MD            
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Dennis Ong, MD FRCPC University of Saskatchewan, Department of Anesthesiology, Perioperative Medicine, and Pain Management
Study Director: Brian Taylor, MD Department of Anesthesiology, Perioperative Medicine, and Pain Management
Study Director: Ashraf Salem, MD Department of Anesthesiology, Perioperative Medicine, and Pain Management
Study Director: Mark Slovack, MD Department of Anesthesiology, Perioperative Medicine, and Pain Management
  More Information

No publications provided

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01277835     History of Changes
Other Study ID Numbers: VATS-lidocaine
Study First Received: April 9, 2010
Last Updated: February 4, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
video-assisted
thoracic surgery
VATS
lidocaine infusion
VATS procedures

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on June 18, 2013