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Completed

NCT Number: NCT01277835

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital

Saskatoon, Saskatchewan, S7M 0Z9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine infusion

Drug

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

Placebo

Drug

Saline Infusion at same rate as experimental arm

Primary outcomes

  1. Verbal Rating Scale for pain with deep inspiration

    Time frame: Up to 48 hrs post-initiation of patient-controlled analgesia

    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.

  2. PCA Morphine Consumption

    Time frame: Up to 48hrs post-initiation of patient-controlled analgesia

    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.

  3. Number of PCA Morphine Requests

    Time frame: Up to 48hrs post-initiation of patient-controlled analgesia

    PCA machines will be reviewed for total number of PCA requests at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.

  4. Verbal Rating Scale for pain at rest

    Time frame: Up to 48hrs post-initiation of patient-controlled analgesia

    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 outcomes

  1. Nausea

    Time frame: Up to 48hrs post-initiation of patient-controlled analgesia

    Patients will be questioned about the side effect of nausea at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.

  2. Vomiting

    Time frame: Up to 48hrs post-initiation of patient-controlled analgesia

    Patients will be questioned about the side effect of vomiting at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.

  3. Pruritus

    Time frame: Up to 48hrs post-initiation of patient-controlled analgesia

    Patients will be questioned about the side effect of pruritus at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.

  4. Constipation

    Time frame: Up to 48hrs post-initiation of patient-controlled analgesia

    Patients will be questioned about the side effect of constipation at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.

  5. Urinary Retention

    Time frame: Up to 48hrs post-initiation of patient-controlled analgesia

    Patients will be questioned about the side effect of urinary retention at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Intravenous Lidocaine Infusion During VATS Procedures Reduces Postoperative Analgesic Requirements

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 17, 2011
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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