Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine
Lidocaine infusion
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 24 Hour Total Opioid Consumption [ Time Frame: 24 hours post surgery ]
    24 hour total opioid consumption using IV morphine equivalents



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I, II,III;
  • BMI > 35 kg/m2,
  • Age between 18-70,
  • Fluent in English,
  • Patients undergoing laparoscopic gastric bypass,
  • EKG within 3 months.

Exclusion Criteria:

  • History of allergy to local anesthetics,
  • History of chronic opioid use,
  • Pregnant patients,
  • History of EKG abnormalities.

Dropout: Conversion to open, patient or surgeon request.


Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Layout table for investigator information
Principal Investigator: Gildasio De Oliveira, M.D Northwestern University
Publications:
Layout table for additonal information
Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01180660    
Other Study ID Numbers: STU00032300
First Posted: August 12, 2010    Key Record Dates
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014
Last Verified: July 2014
Keywords provided by Gildasio De Oliveira, Northwestern University:
Gastric Surgery
Pain
Recovery
Laparoscopic Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action