Systemic Lidocaine Infusion for Pain Control in Ventral Hernia
Primary Purpose
Post Operative Pain
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lidocaine Hydrochloride
Lidocaine Hydrochloride
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
Age over 18 Ventral hernia Elective operation Surgeon anticipates mesh
-
Exclusion Criteria:
Age less than 18 Incapable of informed consent Comorbid condition that precludes lidocaine Pregnancy Emergency procedures No mesh History of narcotic abuse
Sites / Locations
- Carilion Roanoke Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Lidocaine
Arm Description
Patients will receive standard care plus infusion of placebo
Patients will receive lidocaine infusions peri-operatively
Outcomes
Primary Outcome Measures
Post-operative pain
Amount of morphine equivalents opioid medication used 30 days post-op
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03484650
Brief Title
Systemic Lidocaine Infusion for Pain Control in Ventral Hernia
Official Title
Systemic Lidocaine Infusion for Pain Control in Ventral Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of available resources to complete study
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ventral hernia repair leads to more than expected pain. This is thought to be secondary to nerve pain at the lateral transfixion sutures. Systemic lidocaine given pre-op has in other situations decreased neurogenic pain. This study will examine its effects on pain experienced after ventral hernia repair.
Detailed Description
Patients presenting to the surgical clinic for elective repair of ventral hernia defects will be offered the opportunity to participate in a study that aims to reduce post-operative pain. Benefits and risks will be discussed with the patient, and the patient will understand that their decision to opt in or opt out will not affect the minimum standard of care. Once agreeable, the patient will undergo pre-infusion assessment. Such pre-operative evaluation will include complete pain history, quantitative pain assessment, medical history, physical exam, electrocardiogram, and laboratory workup. Specific workup will focus on heart failure or liver disease, as these increase the toxicity of lidocaine. Nevertheless, the low dose of infusion planned is not contraindicated with heart or liver disease. Patients will then be assigned equally and randomly to experimental and control groups. Physicians will be blinded from these assignments. The experimental patient will be treated with IV lidocaine bolus of 1.5 mg/kg and thereafter with infusion at 0.5 mg/kg/hour. Infusion will begin at least one hour prior to incision and continued for 24 hours after incision, unless adverse reactions experienced. Post-operative pain in eight-hour increments will be recorded. Additional opiates required to control pain during admission and after discharge will be recorded. Length of hospital stay will also be documented. The electronic medical record will be utilized to collect the below parameters. The control group will receive standard of care, along with placebo volume and rate of administration of saline equivalent to the volume and rate of the lidocaine infusion. To monitor inpatient pain medication, each patient in the control and experimental group will be prescribed the same analgesia PRN orders. The MAR feature in the electronic patient record will allow determination of the amount of PRN pain medication doses required by each patient. Physicians will be blinded and continue to adjust pain medication orders as needed for optimal patient care. Narcotic requirements for each patient can be standardized to morphine equivalents for analysis.
To monitor outpatient pain medication, each patient in the control and experiential group upon discharge will be given the same analgesia prescriptions, e.g. oxy 5 mg dips #30. Patients will bring back their bottles of pills to be counted at the 2-week post-operative visit. The investigators will call patients at the 30th post-operative day to see how much of the pain medication is in continued use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The patient, physician, and data abstractors will be blinded to the arm.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients will receive standard care plus infusion of placebo
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Patients will receive lidocaine infusions peri-operatively
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Other Intervention Name(s)
Bolus of lidocaine
Intervention Description
Lidocaine bolus to be given 1 hour pre-operatively
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Other Intervention Name(s)
Infusion of lidocaine
Intervention Description
Lidocaine infusion will be started after the bolus and be continued for 24 hours post-operatively
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Control patients will receive a placebo bolus and infusion of saline to match the experimental arm.
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Amount of morphine equivalents opioid medication used 30 days post-op
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18 Ventral hernia Elective operation Surgeon anticipates mesh
-
Exclusion Criteria:
Age less than 18 Incapable of informed consent Comorbid condition that precludes lidocaine Pregnancy Emergency procedures No mesh History of narcotic abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandy L Fogel, MD
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data to be shared.
Learn more about this trial
Systemic Lidocaine Infusion for Pain Control in Ventral Hernia
We'll reach out to this number within 24 hrs