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Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

Primary Purpose

Bariatric Surgical Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Placebo
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bariatric Surgical Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampa General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lidocaine

Placebo

Arm Description

Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr

Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
August 12, 2013
Last Updated
October 25, 2017
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01944098
Brief Title
Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients
Official Title
Systemic Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients: A Randomized, Placebo-Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgical Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
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
Title
Postoperative Pain
Description
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
Title
Postoperative Pain
Description
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
Title
Postoperative Pain
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Karlnoski, PhD
Organizational Affiliation
Florida Gulf-to-Bay Anesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

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Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

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