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

NCT ID: NCT01277835

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine Infusion

Group Type EXPERIMENTAL

Lidocaine Infusion

Intervention Type DRUG

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

Placebo

Saline Infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline Infusion at same rate as experimental arm

Interventions

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Lidocaine Infusion

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

Intervention Type DRUG

Placebo

Saline Infusion at same rate as experimental arm

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis Ong, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

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

Brian Taylor, MD

Role: STUDY_DIRECTOR

Department of Anesthesiology, Perioperative Medicine, and Pain Management

Ashraf Salem, MD

Role: STUDY_DIRECTOR

Department of Anesthesiology, Perioperative Medicine, and Pain Management

Mark Slovack, MD

Role: STUDY_DIRECTOR

Department of Anesthesiology, Perioperative Medicine, and Pain Management

Locations

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St. Paul's Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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VATS-lidocaine

Identifier Type: -

Identifier Source: org_study_id