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

Not Applicable

Completed

• Conditions: Pain; Obesity
• Interventions: Drug: Lidocaine Infusion; Drug: Normal Saline

• Registration Number: NCT01180660
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Results First Submitted: 2014-04-08
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Results First Posted: 2014-08-07
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine Infusion	Lidocaine infusion
Placebo	Normal Saline	Placebo Normal Saline Infusion

Primary Outcome Measures

Name	Time	Method
Quality of Recovery 40 on the Day After Surgery	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

Name	Time	Method
24 Hour Total Opioid Consumption	24 hours post surgery	24 hour total opioid consumption using IV morphine equivalents

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States