Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
Conditions
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.
Interventions
DRUGLidocaine
1% Lidocaine 1mg/kg/hr IV drip x 48hr
PROCEDUREEpidural Block
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
DRUGPCA Morphine
PCA 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.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative functional recovery | daily during hospitalization, and at 4 and 8 weeks after the surgery |
Secondary
| Measure | Time frame |
|---|---|
| postoperative pain | daily during hospitalization |
| opioid consumption | daily during hospitalization |
| opioid side effects | daily during hospitalization |
Countries
Canada
Outcome results
None listed