IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01180660|
Recruitment Status : Completed
First Posted : August 12, 2010
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain Obesity||Drug: Lidocaine Infusion Drug: Normal Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effect of Systemic Intraoperative Lidocaine on Postoperative Pain and Quality of Recovery on Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||November 2012|
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
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
- Quality of Recovery 40 on the Day After Surgery [ Time Frame: 24 hours ]
Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high.
The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery.
- 24 Hour Total Opioid Consumption [ Time Frame: 24 hours post surgery ]24 hour total opioid consumption using IV morphine equivalents
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180660
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Gildasio De Oliveira, M.D||Northwestern University|