IV Lidocaine in Pediatric AIS
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 12 - 18 |
| Updated: | 3/30/2019 |
| Start Date: | May 1, 2019 |
| End Date: | July 31, 2023 |
| Contact: | Elfaridah P Frazier, PhD |
| Email: | e.p.frazier@wustl.edu |
| Phone: | 3147472574 |
Intravenous Lidocaine to Reduce Postoperative Opioid Consumption and Improve Recovery After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
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.
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.
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.
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.
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
We found this trial at
1
site
4940 Forest Park Avenue
Saint Louis, Missouri 63108
Saint Louis, Missouri 63108
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