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

NCT01277835 | Completed

• 1 other identifier: VATS-lidocaine
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

video-assisted; thoracic surgery; VATS; lidocaine infusion; VATS procedures

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Nausea

  Up to 48hrs post-initiation of patient-controlled analgesia

• Vomiting

  Up to 48hrs post-initiation of patient-controlled analgesia

• Pruritus

  Up to 48hrs post-initiation of patient-controlled analgesia

• Constipation

  Up to 48hrs post-initiation of patient-controlled analgesia

• Urinary Retention

  Up to 48hrs post-initiation of patient-controlled analgesia

Study Arms (2)

Lidocaine Infusion

EXPERIMENTAL

Drug: Lidocaine Infusion

Placebo

PLACEBO COMPARATOR

Saline Infusion

Drug: Placebo

Interventions

Lidocaine Infusion DRUG

Infusion of lidocaine 3mg/min or 2mg/min during surgery

Lidocaine Infusion

Placebo DRUG

Saline Infusion at same rate as experimental arm

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

St. Paul's Hospital

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis Ong, MD FRCPC

  University of Saskatchewan, Department of Anesthesiology, Perioperative Medicine, and Pain Management

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: January 17, 2011
• Study Start: February 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2013-02

Locations

CA (1)