Title
Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients
Systemic Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients: A Randomized, Placebo-Controlled Pilot Study
Phase
Phase 3Lead Sponsor
University of South FloridaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Bariatric Surgical PainIntervention/Treatment
lidocaine ...Study Participants
20The 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.
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
| Event Type | Organ System | Event Term | Lidocaine | Placebo |
|---|
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
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
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
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
