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Post Operative Functional Restoration in Patients Undergoing Major Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine


N/A
18 Years
85 Years
Not Enrolling
Both
Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis

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Trial Information

Post Operative Functional Restoration in Patients Undergoing Major Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine


This is a blinded randomised study of patients undergoing major laparoscopic abdominal and
pelvic surgery. The first group of patients will receive thoracic epidural analgesia, the
second group will receive perioperative intravenous lidocaine, the third group will PCA
alone and the last group will receive spinal analgesia. Functional restoration assessed by
self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min
walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.


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

- allergy to lidocaine

- morbid obesity

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 functional recovery

Outcome Time Frame:

daily during hospitalization, and at 4 and 8 weeks after the surgery

Safety Issue:

No

Principal Investigator

Franco Carli, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University Healt Centre

Authority:

Canada: Ethics Review Committee

Study ID:

GEN-06-023

NCT ID:

NCT00982618

Start Date:

July 2009

Completion Date:

June 2011

Related Keywords:

  • Colon Cancer
  • Inflammatory Bowel Diseases
  • Diverticulitis
  • Colonic Neoplasms
  • Diverticulitis
  • Inflammatory Bowel Diseases
  • Intestinal Diseases

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