Clinical trial NCT03893318: IV Lidocaine in Pediatric AIS
Official title: Intravenous Lidocaine to Reduce Postoperative Opioid Consumption and Improve Recovery After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized, triple-blind, placebo-controlled trial of intravenous lidocaine in the management of surgery performed for adolescent idiopathic scoliosis.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Opioid consumption
timeFrame: up to 6 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital and St. Louis Children Hospital / Washington University in St. Louis School of Medicine
state: Missouri
Study officials:
affiliation: St. Louis Children's Hospital
name: Scott Luhmann, MD
role: PRINCIPAL_INVESTIGATOR
References: