Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

Study Overview
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Brief Summary
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The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.

Official Title
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Systemic Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients: A Randomized, Placebo-Controlled Pilot Study

Conditions
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Bariatric Surgical Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients between the ages of 18-65 years old BMI ≥ 40 kg/m2, ≤ 60 kg/m2 Undergoing a primary laparoscopic RYGB by Dr. Murr Agree to be followed 24 hours postoperatively Normal K+ and Mg++ serum levels Exclusion Criteria: BMI less than 40 kg/m2, > 60 kg/m2 Laparoscopic RYGB surgery performed by a surgeon other than Dr. Murr Allergy to lidocaine Allergy to hydromorphone or ketorolac Allergy to corn or amide anesthetics Use of (thioridizine) Pregnancy Abnormalities of ALT or AST Intra-operative diagnosis of cirrhosis or portal hypertension Intraoperative complications per surgeon Intraoperative extensive adhesions per surgeon Chronic pain syndrome and chronic use of narcotics Severe back pain secondary to degenerative joint disease

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Lidocaine<br>Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr | Drug: Lidocaine<br> <br> |
| Active Comparator: Placebo<br>Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain | 6 hours post-surgery | 
| Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting | 12 hours post-surgery | 
| Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting | 18 hours post-surgery | 
| Postoperative Pain | Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain | 24 hours post-surgery |