Clinical trial NCT00982618: Functional Restoration After Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine
Official title: Post Operative Functional Restoration in Patients Undergoing Major Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Inflammatory Bowel Diseases
Diverticulitis
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early post operative physical activity recovery of patients scheduled for laparoscopic colon surgery.

Twenty patients will receive thoracic epidural analgesia, twenty patients will receive intravenous lidocaine plus patient-controlled analgesia (PCA) and twenty patients will receive only PCA.

Hypothesis: patients receiving perioperative intravenous lidocaine, post operative recovery will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.

Detailed description: 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.

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
* allergy to lidocaine
* morbid obesity

Primary outcomes:
measure: Postoperative functional recovery
timeFrame: daily during hospitalization, and at 4 and 8 weeks after the surgery
Secondary outcomes:
measure: postoperative pain
timeFrame: daily during hospitalization
measure: opioid consumption
timeFrame: daily during hospitalization
measure: opioid side effects
timeFrame: daily during hospitalization
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Healt Centre
name: Franco Carli, Professor
role: PRINCIPAL_INVESTIGATOR
References: