Trial Information
Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
This is a blinded randomized controlled trial in patients undergoing laparoscopic colon
surgery. The aim of this study is to assess whether spinal analgesia with a mixture of
bupivacaine and morphine provides better pain relief than systemic morphine in a group of
patients undergoing colonic resection and using the ERAS program.
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
- morbid obesity
- contraindication to spinal analgesia
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
postoperative pain
Outcome Time Frame:
daily during hospitalization up to 3 days after the operation
Safety Issue:
No
Principal Investigator
Franco Carli, Professor
Investigator Role:
Study Director
Investigator Affiliation:
McGill University Health Center
Authority:
Canada: Health Canada
Study ID:
GEN-06-023(2)
NCT ID:
NCT01477190
Start Date:
October 2010
Completion Date:
October 2011
Related Keywords:
- Colon Cancer
- Inflammatory Bowel Diseases
- Diverticulitis
- Colonic Neoplasms
- Diverticulitis
- Inflammatory Bowel Diseases
- Intestinal Diseases