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WithdrawnNCT03484650Updated Feb 1, 2021

Systemic Lidocaine Infusion for Pain Control in Ventral Hernia

A Phase 3 interventional study of Lidocaine Hydrochloride and Lidocaine Hydrochloride in Post Operative Pain, sponsored by Carilion Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Carilion Clinic · Phase 3, Interventional, and Prevention

Why this study was withdrawn
Lack of available resources to complete study
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Post Operative Pain

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03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

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Lead sponsor

Carilion Clinic is the lead sponsor of 75 studies on the registry; 15 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 2 (22%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age over 18 Ventral hernia Elective operation Surgeon anticipates mesh

Exclusion criteria

-

Exclusion Criteria:

Age less than 18 Incapable of Comorbid condition that precludes lidocaine Pregnancy Emergency procedures No mesh History of narcotic abuse

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Control

    Patients will receive standard care plus infusion of placebo

    Other: Placebo

  • Experimental
    Lidocaine

    Patients will receive lidocaine infusions peri-operatively

    Drug: Lidocaine Hydrochloride

Interventions

  • Lidocaine bolus to be given 1 hour pre-operatively

    Also known as: Bolus of lidocaine

  • Lidocaine infusion will be started after the bolus and be continued for 24 hours post-operatively

    Also known as: Infusion of lidocaine

  • OtherPlacebo

    Control patients will receive a placebo bolus and infusion of saline to match the experimental arm.

06

What researchers measure

Primary outcomes

  1. Post-operative pain

    Amount of morphine equivalents opioid medication used 30 days post-op

    Time frame: 30 days

07

Study locations

1 site
  • Carilion Roanoke Memorial Hospital
    Roanoke, Virginia 24016, United States
08

References and documents

Individual participant data

Plan to share: No — No data to be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2020 (actual). Primary completion is estimated for Dec 2022, 34 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2018
First posted
Apr 2, 2018
StartActual
Jan 14, 2020
Primary completionEst.
Dec 1, 2022
CompletionEst.
Dec 1, 2022
Last update
Feb 1, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03484650
Lead sponsor
Carilion Clinic
Responsible party
Curtis Bower (Vice Chief of Carilion Clinic General Surgery, Carilion Clinic) — Principal investigator
First posted
Apr 2, 2018
Start date
Jan 14, 2020
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Feb 1, 2021

Study contacts

Sandy L Fogel, MD
principal investigator · Carilion Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Lidocaine

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