Systemic Lidocaine Infusion for Pain Control in Ventral Hernia

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.

Study Overview

• Status: Withdrawn
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: Placebo; Drug: Lidocaine Hydrochloride; Drug: Lidocaine Hydrochloride

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Carilion Roanoke Memorial 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:

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

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
Placebo Comparator: Control; Patients will receive standard care plus infusion of placebo	Other: Placebo; Control patients will receive a placebo bolus and infusion of saline to match the experimental arm.
Experimental: Lidocaine; Patients will receive lidocaine infusions peri-operatively	Drug: Lidocaine Hydrochloride; Lidocaine bolus to be given 1 hour pre-operatively; Other Names: Bolus of lidocaine; Drug: Lidocaine Hydrochloride; Lidocaine infusion will be started after the bolus and be continued for 24 hours post-operatively; Other Names: Infusion of lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	Amount of morphine equivalents opioid medication used 30 days post-op	30 days

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: Sandy L Fogel, MD, Carilion Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Pain, Postoperative; Hernia, Ventral; 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: 2344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data to be shared.

Drug and device information, study documents

• 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