Clinical trial NCT01277835: Intravenous Lidocaine Infusion During Video-assisted Thoracic Procedures for Improved Pain Control
Official title: Intravenous Lidocaine Infusion During VATS Procedures Reduces Postoperative Analgesic Requirements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: video-assisted
thoracic surgery
VATS
lidocaine infusion
VATS procedures
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Verbal Rating Scale for pain with deep inspiration
timeFrame: Up to 48 hrs post-initiation of patient-controlled analgesia
measure: PCA Morphine Consumption
timeFrame: Up to 48hrs post-initiation of patient-controlled analgesia
measure: Number of PCA Morphine Requests
timeFrame: Up to 48hrs post-initiation of patient-controlled analgesia
measure: Verbal Rating Scale for pain at rest
timeFrame: Up to 48hrs post-initiation of patient-controlled analgesia
Secondary outcomes:
measure: Nausea
timeFrame: Up to 48hrs post-initiation of patient-controlled analgesia
measure: Vomiting
timeFrame: Up to 48hrs post-initiation of patient-controlled analgesia
measure: Pruritus
timeFrame: Up to 48hrs post-initiation of patient-controlled analgesia
measure: Constipation
timeFrame: Up to 48hrs post-initiation of patient-controlled analgesia
measure: Urinary Retention
timeFrame: Up to 48hrs post-initiation of patient-controlled analgesia
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: St. Paul's Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan, Department of Anesthesiology, Perioperative Medicine, and Pain Management
name: Dennis Ong, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Perioperative Medicine, and Pain Management
name: Brian Taylor, MD
role: STUDY_DIRECTOR
affiliation: Department of Anesthesiology, Perioperative Medicine, and Pain Management
name: Ashraf Salem, MD
role: STUDY_DIRECTOR
affiliation: Department of Anesthesiology, Perioperative Medicine, and Pain Management
name: Mark Slovack, MD
role: STUDY_DIRECTOR
References: