Systemic Lidocaine Infusion for Pain Control in Ventral Hernia



Status:Recruiting
Conditions:Post-Surgical Pain, Gastrointestinal
Therapuetic Areas:Gastroenterology, Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:October 1, 2018
End Date:December 1, 2019
Contact:Sandy L Fogel, MD
Email:slfogle@carilionclinic.org
Phone:540 589 4980

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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.

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.

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
We found this trial at
1
site
Roanoke, Virginia 24033
Phone: 540-520-5484
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Roanoke, VA
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