Clinical Trials Directory

Trials / Completed

CompletedNCT00982618

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

Post Operative Functional Restoration in Patients Undergoing Major Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGLidocaine1% Lidocaine 1mg/kg/hr IV drip x 48hr
PROCEDUREEpidural Block0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
DRUGPCA MorphinePCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.

Timeline

Start date
2009-07-01
Primary completion
2010-06-01
Completion
2011-06-01
First posted
2009-09-23
Last updated
2011-11-28

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00982618. Inclusion in this directory is not an endorsement.