Functional Restoration After Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982618
• Other study ID #: GEN-06-023
• Status: Completed
• Phase: N/A
• First received: September 22, 2009
• Last updated: November 24, 2011
• Start date: July 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer
• Diverticulitis
• Inflammatory Bowel Diseases

Intervention

Drug:
• Lidocaine
1% Lidocaine 1mg/kg/hr IV drip x 48hr

Procedure:
• Epidural Block
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr

Drug:
• PCA Morphine
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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative functional recovery		daily during hospitalization, and at 4 and 8 weeks after the surgery	No
Secondary	postoperative pain		daily during hospitalization	No
Secondary	opioid consumption		daily during hospitalization	Yes
Secondary	opioid side effects		daily during hospitalization	Yes