IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01180660
First received: July 19, 2010
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention
Pain
Obesity
Drug: Lidocaine Infusion
Drug: Normal Saline

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Quality of Recovery 40 on the Day After Surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    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:
  • 24 Hour Total Opioid Consumption [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]
    24 hour total opioid consumption using IV morphine equivalents


Enrollment: 51
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01180660

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio De Oliveira, M.D Northwestern University
  More Information

Publications:

Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01180660     History of Changes
Other Study ID Numbers: STU00032300
Study First Received: July 19, 2010
Results First Received: April 8, 2014
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Gastric Surgery
Pain
Recovery
Laparoscopic Surgery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014