Functional Restoration After Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine

Not Applicable

Completed

• Conditions: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis
• Interventions: Procedure: Epidural Block; Drug: PCA Morphine; Drug: Lidocaine

• Registration Number: NCT00982618
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early post operative physical activity recovery of patients scheduled for laparoscopic colon surgery.

Twenty patients will receive thoracic epidural analgesia, twenty patients will receive intravenous lidocaine plus patient-controlled analgesia (PCA) and twenty patients will receive only PCA.

Hypothesis: patients receiving perioperative intravenous lidocaine, post operative recovery will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.

Detailed Description

This is a blinded randomised study of patients undergoing major laparoscopic abdominal and pelvic surgery. The first group of patients will receive thoracic epidural analgesia, the second group will receive perioperative intravenous lidocaine, the third group will PCA alone and the last group will receive spinal analgesia. Functional restoration assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2010-06
• Study Completion: 2011-06
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-24
• Last Update Posted: 2011-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients scheduled to undergo laparoscopic colonic resection

Exclusion Criteria

• patients who have trouble to understand, read or communicate either in French or in English
• dementia
• patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
• patients suffering from severe cardiac or respiratory disease (status ASA IV)
• patients suffering from metastatic carcinoma
• patients who have a history of chemoradiation within the six months preceding surgery
• allergy to lidocaine
• morbid obesity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Group	Epidural Block	Epidural Group: Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.
PCA group	PCA Morphine	Beside general anesthesia, the patients will receive neither lidocaine nor epidural catheter. The patients will receive the same analgesia protocol consisting of PCA morphine for a total duration of 48 hours.
LIDOCAINE group	Lidocaine	LIDOCAINE group : Beside general anesthesia, patients will receive intravenous lidocaine bolus 1.5 mg/kg just prior induction and an infusion of lidocaine 2mg/kg/h will be started and maintained during the whole surgical procedure. Entering the recovery room, this infusion will be decreased at the rate of 1mg/kg/hour for the 48 first hours

Primary Outcome Measures

Name	Time	Method
Postoperative functional recovery	daily during hospitalization, and at 4 and 8 weeks after the surgery

Secondary Outcome Measures

Name	Time	Method
postoperative pain	daily during hospitalization
opioid consumption	daily during hospitalization
opioid side effects	daily during hospitalization

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada