IV Lidocaine in Pediatric AIS

NCT ID: NCT03893318

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Study Group

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

Group Type: EXPERIMENTAL

IV lidocaine

Intervention Type: 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.

Control Group

will receive saline placebo during and after surgery.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Saline

Interventions

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.

Intervention Type: DRUG

Placebos

Saline

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Luhmann, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis Children's Hospital

Locations

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

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

201807071

Identifier Type: -

Identifier Source: org_study_id