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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Systemic Intraoperative Lidocaine on Postoperative Pain and Quality of Recovery on Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery

Conditions
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Pain, Obesity

Intervention / Treatment
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* Drug: Lidocaine Infusion
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Lidocaine infusion | Drug: Lidocaine Infusion<br>* 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period<br>|
| Placebo Comparator: Placebo<br>Placebo Normal Saline Infusion | Drug: Normal Saline<br>* Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period<br>* Other names: Placebo infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery 40 on the Day After Surgery | 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 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 Hour Total Opioid Consumption | 24 hour total opioid consumption using IV morphine equivalents | 24 hours post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Surgery, Pain, Recovery, Laparoscopic Surgery