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

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 Overview

• Status: Completed
• Conditions: Bariatric Surgical Pain
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine; Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr	Drug: Lidocaine
Active Comparator: Placebo; Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr	Drug: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Study Director: Rachel Karlnoski, PhD, Florida Gulf-to-Bay Anesthesiology

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 12, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 17, 2013

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Pro00002417