IV Lidocaine in Pediatric AIS

Phase 4

• Conditions: Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery
• Interventions: Drug: IV lidocaine; Drug: Placebos

• Registration Number: NCT03893318
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-28
• Study Start: 2019-07-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	IV lidocaine	will receive intravenous lidocaine during and after posterior spinal fusion for AIS
Control Group	Placebos	will receive saline placebo during and after surgery.

Primary Outcome Measures

Name	Time	Method
Opioid consumption	up to 6 weeks after surgery	measured in morphine-equivalent dosage (MED)

Trial Locations

Locations (1)

Barnes Jewish Hospital and St. Louis Children Hospital / Washington University in St. Louis School of Medicine; 🇺🇸 Saint Louis, Missouri, United States