Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program

Study Overview
=================
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.

Official Title
-----------------
Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program

Conditions
-----------------
Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis

Intervention / Treatment
-----------------
* Drug: Spinal analgesia
* Drug: Patient Control Analgesia (PCA) Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal group<br>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. | Drug: Spinal analgesia<br>* 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.<br>* Other names: Spinal block, intrathecal block;|
| Active Comparator: PCA group<br>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. | Drug: Patient Control Analgesia (PCA) Morphine<br>* 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.<br>* Other names: Patient Control Analgesia Morphine.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | daily during hospitalization up to 3 days after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |