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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Lidocaine Infusion

• Registration Number: NCT01277835
• Lead Sponsor: University of Saskatchewan

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.

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline Infusion
Lidocaine Infusion	Lidocaine Infusion	-

Primary Outcome Measures

Name	Time	Method
PCA Morphine Consumption	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.
Verbal Rating Scale for pain at rest	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.
Number of PCA Morphine Requests	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.
Verbal Rating Scale for pain with deep inspiration	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.

Secondary Outcome Measures

Name	Time	Method
Constipation	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.
Nausea	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.
Vomiting	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.
Pruritus	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.
Urinary Retention	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.

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada