IV Lidocaine in Pediatric AIS

NCT03893318 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 201807071
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  measured in morphine-equivalent dosage (MED)

  up to 6 weeks after surgery

Study Arms (2)

Study Group

EXPERIMENTAL

will receive intravenous lidocaine during and after posterior spinal fusion for AIS

Drug: IV lidocaine

Control Group

PLACEBO COMPARATOR

will receive saline placebo during and after surgery.

Drug: Placebos

Interventions

IV lidocaine DRUG

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.

Study Group

Placebos DRUG

Saline

Control Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Age \< 12 or \> 18 years old.
• 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.
• Diagnosis of sepsis or infection
• Diagnosis of primary or metastatic malignancy.
• Participation in another clinical trial.
• Past or current diagnoses of a cardiac arrhythmia or first/second degree heart block.
• Past or current seizure disorders.
• Allergy to bupivacaine.
• Planned anterior approaches for treatment of scoliosis deformity.
• Limited English proficiency (e.g. unable to obtain informed consent for surgery without a translator)
• Ward of the State children

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Jewish Hospital and St. Louis Children Hospital / Washington University in St. Louis School of Medicine

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Michael Kelly, MD
• Organization: University of California, San Diego

mpkelly@ucsd.edu

508-410-9567

Study Officials

• Scott Luhmann, MD

  St. Louis Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study Drug
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized, triple-blind, placebo-controlled trial of intravenous lidocaine in the management of surgery performed for adolescent idiopathic scoliosis.

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 28, 2019
• Study Start: July 30, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-10

Locations

US (1)