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IV Lidocaine in Pediatric AIS (PEDS LIDO)

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ClinicalTrials.gov Identifier: NCT03893318
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid method of post-operative pain management following postoperative spinal fusion for adolescent idiopathic scoliosis (AIS). The outcomes assessed will be (1) the effect of intravenous lidocaine on post-operative opioid consumption, both in-hospital and at three-month follow-up, (2) the effect of intravenous lidocaine on the immunophenotype expressed following surgery, and (3) the effect of intravenous lidocaine on recovery from surgery as assessed by the Patient Reported Outcomes Measurement Information System-Computer Adaptive Tests for Pain Interference (PI) and Mobility (M) (PROMIS-CAT). Thus, we propose a study of a non-opioid method of pain control to minimize opioid consumption in-hospital and at three-months postoperatively, with primary outcomes measures that include morphine-equivalent opioid consumption and PROMIS-Mobility to assess recovery. In addition, we will test the ability of systemic lidocaine to attenuate the systemic inflammatory response to major spine surgery. The immunologic response to surgery has been associated with rehabilitation and recovery following total hip arthroplasty and this study will provide data to support further work.

Condition or disease Intervention/treatment Phase
Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery Drug: IV lidocaine Drug: Placebos Phase 4

Detailed Description:
a Phase IV, randomized, triple-blind, placebo-controlled trial with two study groups: postoperative standard of care with opioid patient controlled analgesia (PCA) and IV lidocaine infusion versus postoperative standard of care plus normal saline placebo. Block randomization into one of the two groups will be based on a random table generated using an R-program. Group 1 (Study) will receive intravenous lidocaine during and after posterior spinal fusion for AIS. Group 2 (Control) will receive saline placebo during and after surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomized, triple-blind, placebo-controlled trial of intravenous lidocaine in the management of surgery performed for adolescent idiopathic scoliosis.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study Drug
Primary Purpose: Treatment
Official Title: Intravenous Lidocaine to Reduce Postoperative Opioid Consumption and Improve Recovery After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group
will receive intravenous lidocaine during and after posterior spinal fusion for AIS
Drug: IV lidocaine
an amide-type, short-acting local anesthetic and delivered as an aqueous solution for intravenous administration. It has a half-life of 1.5-2 hours. A traditional method of administration is via epidural delivery. Epidural lidocaine is effective and this effect is due, in part, to systemic absorption. Systemic (intravenous) administration of lidocaine is a Food and Drug Administration approved method of delivery. Low plasma levels are needed for effective use, 0.5µg/mL to 5.0µg/mL. Given this low concentration required and the short half-life, continuous infusion of lidocaine is thought to be generally safe with low risk of complication.

Placebo Comparator: Control Group
will receive saline placebo during and after surgery.
Drug: Placebos
Saline




Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: up to 6 weeks after surgery ]
    measured in morphine-equivalent dosage (MED)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adolescent idiopathic scoliosis indicated for posterior spinal fusion.
  2. Ages between 12 and 18 years of age.
  3. Parent/Guardian capable of providing informed consent for study participation

Exclusion Criteria:

  1. Age < 12 or > 18 years old.
  2. Unable to obtain consent for the surgical intervention or study, or if mental capacity prohibits the ability to provide consent and complete patient-reported outcomes tools.
  3. Diagnosis of sepsis or infection
  4. Diagnosis of primary or metastatic malignancy.
  5. Participation in another clinical trial.
  6. Past or current diagnoses of a cardiac arrhythmia or first/second degree heart block.
  7. Past or current seizure disorders.
  8. Allergy to bupivacaine.
  9. Planned anterior approaches for treatment of scoliosis deformity.
  10. Limited English proficiency (e.g. unable to obtain informed consent for surgery without a translator)
  11. Ward of the State children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893318


Contacts
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Contact: Elfaridah P Frazier, PhD 3147472574 e.p.frazier@wustl.edu

Locations
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United States, Missouri
Barnes Jewish Hospital and St. Louis Children Hospital / Washington University in St. Louis School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Michael P Kelly, MD    314-747-2600    kellymi@wudosis.wustl.edu   
Principal Investigator: Michael P Kelly, MD         
Sponsors and Collaborators
Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03893318    
Other Study ID Numbers: 201807071
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: Yes
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action