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


Phase 1/Phase 2
18 Years
90 Years
Not Enrolling
Both
Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis

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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

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