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

Primary Purpose

Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Spinal analgesia
Patient Control Analgesia (PCA) Morphine
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal group

PCA group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

postoperative pain

Secondary Outcome Measures

opioid consumption
opioid side effects

Full Information

First Posted
November 16, 2011
Last Updated
November 24, 2011
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01477190
Brief Title
Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
Official Title
Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal group
Arm Type
Experimental
Arm Description
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.
Arm Title
PCA group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Spinal analgesia
Other Intervention Name(s)
Spinal block, intrathecal block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Patient Control Analgesia (PCA) Morphine
Other Intervention Name(s)
Patient Control Analgesia Morphine.
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative pain
Time Frame
daily during hospitalization up to 3 days after the operation
Secondary Outcome Measure Information:
Title
opioid consumption
Time Frame
daily during hospitalization up to 3 days after the operation
Title
opioid side effects
Time Frame
daily during hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Carli, Professor
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Study Director
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada

12. IPD Sharing Statement

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

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