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

Pain Clinical Trial

Official title:

Intravenous Lidocaine Infusion During VATS Procedures Reduces Postoperative Analgesic Requirements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277835
• Other study ID #: VATS-lidocaine
• Status: Completed
• Phase: N/A
• First received: April 9, 2010
• Last updated: December 1, 2014
• Start date: February 2010
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine Infusion
Infusion of lidocaine 3mg/min or 2mg/min during surgery
• Placebo
Saline Infusion at same rate as experimental arm

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No