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Post Operative PainPhase 3NCT03484650

Systemic Lidocaine Infusion for Pain Control in Ventral Hernia

A Phase 3 study testing Lidocaine Hydrochloride in people with Post Operative Pain, run by Carilion Clinic at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Operative Pain
What is being tested?
Lidocaine Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
14 Jan 2020to 1 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18 Ventral hernia Elective operation Surgeon anticipates mesh
  • -

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24016

Other trials in United States

About this study

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.

Being tested
Lidocaine Hydrochloride, Placebo
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine HydrochlorideDrug

    Also called Bolus of lidocaine

    Lidocaine bolus to be given 1 hour pre-operatively

  • Lidocaine HydrochlorideDrug

    Also called Infusion of lidocaine

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

  • PlaceboOther

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

Study groups in NCT03484650
Study groupRoleWhat they receive
ControlPlacebo comparatorPatients will receive standard care plus infusion of placebo
Receives: Other: Placebo
LidocaineExperimentalPatients will receive lidocaine infusions peri-operatively
Receives: Drug: Lidocaine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-operative pain

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2018
  2. Study start14 Jan 2020
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Why it stopped: Lack of available resources to complete study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized controlled trial
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03484650
Sponsor's protocol ID
2344
Status last verified
Jan 2021
First submitted
26 Mar 2018
Last updated
1 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No data to be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lidocaine Hydrochloride in people with Post Operative Pain, run by Carilion Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative pain (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.

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