Colon Cancer, Diverticulitis, Inflammatory Bowel Diseases
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 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 Enhanced Recovery After Surgery (ERAS) program. Twenty patients will receive spinal analgesia and twenty patients will receive only Patient Control Analgesia (PCA).
Detailed description
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.
Interventions
DRUGSpinal analgesia
isobaric bupivacaine 0.5% 10 mg together with preservative-free morphine was injected. The dose of morphine was based on patient's age, with 200 μg in patients aged ≤ 75 years and 150 μg in patients aged \> 75 years.
DRUGPatient Control Analgesia (PCA) 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 90 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 * morbid obesity * contraindication to spinal analgesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative pain | daily during hospitalization up to 3 days after the operation |
Secondary
| Measure | Time frame |
|---|---|
| opioid consumption | daily during hospitalization up to 3 days after the operation |
| opioid side effects | daily during hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days |
Countries
Canada
Outcome results
None listed