IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery
Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery.
This study has the potential to confirm an opioid sparing strategy for morbid obese patients undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea and the increased risk of postoperative hypoxemia make the development of opioid sparing techniques in this patient population warranted.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||The Effect of Systemic Intraoperative Lidocaine on Postoperative Pain and Quality of Recovery on Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery|
- 24 hour opioid consumption post surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]24 hour opioid consumption post surgery will be compared between groups.
- Quality of recovery 40 on the day after surgery [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]Quality of recovery 40 questionnaire scores on the day after surgery will be compared between groups.
|Study Start Date:||June 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Lidocaine
Drug: Lidocaine Infusion
1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period
Other Name: Lidocaine Infusion
Placebo Comparator: Placebo
Placebo Normal Saline Infusion
Drug: Normal Saline
Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period
Other Name: Placebo infusion
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180660
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Gildasio De Oliveira, M.D||Northwestern University|