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 Withdrawn at 1 site in United States.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
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
Browse Pain, Postoperative studies →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.
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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.
Age over 18 Ventral hernia Elective operation Surgeon anticipates mesh
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Exclusion Criteria:
Age less than 18 Incapable of Comorbid condition that precludes lidocaine Pregnancy Emergency procedures No mesh History of narcotic abuse
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive standard care plus infusion of placebo
Other: Placebo
Patients will receive lidocaine infusions peri-operatively
Drug: Lidocaine Hydrochloride
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
Control patients will receive a placebo bolus and infusion of saline to match the experimental arm.
Post-operative pain
Amount of morphine equivalents opioid medication used 30 days post-op
Time frame: 30 days
Plan to share: No — No data to be shared.
No publications or documents are linked to this record.
Started Jan 2020 (actual). Primary completion is estimated for Dec 2022, 34 months after the start.
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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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