Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

Phase 3CompletedNCT01944098

University of South Florida20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Bariatric Surgical Pain

Interventions

LidocaineDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tampa General Hospital

Tampa, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 24 hours post-surgery

Data from ClinicalTrials.gov

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