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

Intravenous Lidocaine Infusion During VATS Procedures Reduces Postoperative Analgesic Requirements

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Lidocaine Infusion; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7M 0Z9
      • St. Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Rating Scale for pain with deep inspiration	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.	Up to 48 hrs post-initiation of patient-controlled analgesia
PCA Morphine Consumption	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.	Up to 48hrs post-initiation of patient-controlled analgesia
Number of PCA Morphine Requests	PCA machines will be reviewed for total number of PCA requests at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.	Up to 48hrs post-initiation of patient-controlled analgesia
Verbal Rating Scale for pain at rest	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.	Up to 48hrs post-initiation of patient-controlled analgesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea	Patients will be questioned about the side effect of nausea at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.	Up to 48hrs post-initiation of patient-controlled analgesia
Vomiting	Patients will be questioned about the side effect of vomiting at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.	Up to 48hrs post-initiation of patient-controlled analgesia
Pruritus	Patients will be questioned about the side effect of pruritus at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.	Up to 48hrs post-initiation of patient-controlled analgesia
Constipation	Patients will be questioned about the side effect of constipation at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.	Up to 48hrs post-initiation of patient-controlled analgesia
Urinary Retention	Patients will be questioned about the side effect of urinary retention at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.	Up to 48hrs post-initiation of patient-controlled analgesia

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: April 9, 2010
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (ESTIMATE): January 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: thoracic surgery; VATS; video-assisted; lidocaine infusion; VATS procedures
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: VATS-lidocaine