IV Lidocaine Analgesia in Pediatric Scoliosis Surgery

Study Overview
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Brief Summary
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Surgical correction of scoliosis in children is a long procedure, with an equivalently long recovery time, that is commonly performed at BC Children's Hospital. Treating pain immediately after the procedure is a priority for children during recovery. Morphine is one medication that can be used to manage post-operative pain, but unfortunately, its use is accompanied by a number of side effects which can affect recovery. These include nausea, vomiting, pruritus, sedation, dysphoria, respiratory depression, constipation, ileus, and urinary retention. In order to control pain and reduce morphine consumption, intravenous lidocaine is being investigated. This therapy has been beneficial in adult populations undergoing abdominal surgery and has been associated with decreased post-operative pain, decrease use of opioids including morphine, and ileus. These all contribute to shorter lengths of stay in the hospital and better recovery in the adult population. Intravenous lidocaine is used by some anesthesiologists at BC Children's Hospital to manage post-operative pain in children receiving surgical correction for scoliosis, but this is not a standard of practice. We now propose to conduct a double-blind randomized controlled trial to determine if intravenous lidocaine, infused from start of anesthesia up to 48 hours post-operatively, will reduce morphine use and improve post-operative pain in the pediatric population.

Detailed Description
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Objectives: The primary objective of this study is to determine if perioperative IV lidocaine therapy (P-IVLT) reduces 48-hour post-operative morphine utilization compared with a control, in adolescents undergoing PSIF. Secondary objectives of this study are to determine the effect of P-IVLT on self-reported pain scores, time to documented first stand, time to first walk of greater than 15 steps, and length of hospital stay (LOS). Research Methods: This will be a placebo-controlled, double-blind randomized control trial (RCT) comparing 48-hour postoperative morphine utilization among adolescents undergoing PSIF who have been randomly assigned to one of two groups: Intervention group (A) will receive P-IVLT in addition to the standard multimodal analgesia. P-IVLT will consist of 1 mg/kg bolus at start of anesthesia (T0), followed by 2 mg·kg-1·hr-1 infusion for 8 hours (T1), then continued at 1 mg·kg-1·hr-1 infusion thereafter and postoperatively until T0 + 48 hours (T2). Control group (B) will receive a placebo (0.9% sodium chloride also known as normal saline), made to mimic the intervention protocol above, in addition to the standard multimodal analgesia.

Official Title
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Perioperative Multimodal Analgesia Including Intravenous Lidocaine Infusion for Pain Management Following Idiopathic Scoliosis Correction Surgery in Children

Conditions
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Scoliosis; Adolescence, Anesthesia Recovery Period

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III Diagnosed with Idiopathic scoliosis Undergoing single-stage posterior spinal instrumentation and fusion Exclusion Criteria: Thorascopic tethering procedure Two-stage procedure Abnormal developmental profile Congenital/neuromuscular scoliosis Requiring PICU admission Known allergy to lidocaine Known cardiac, renal or liver disease or dysfunction Pre-existing pain complaints, i.e. on regular analgesic medications Current psychiatric diagnosis, e.g. anxiety, depression, eating disorder, defined according to DSM criteria. Requiring non-standard post-op pain management Any history of seizures Unplanned staged procedure Weight < 5th centile or > 85th centile for age Porphyria

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a placebo-controlled, double-blind randomized control trial (RCT) comparing 48-hour postoperative morphine utilization amongst adolescents undergoing posterior spinal instrumentation and fusion who have been randomly assigned to one of two groups: Intervention group will receive perioperative IV lidocaine therapy (1% preservative free lidocaine 10 mg/ml in 0.9% NaCl) in addition to the standard multi-modal analgesia. Control group will receive a placebo (0.9% sodium chloride also known as normal saline), made to mimic the intervention.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous lidocaine<br>1% preservative free lidocaine 10 mg/ml in 0.9% NaCl | Drug: Lidocaine<br>* Intervention group (A) will receive P-IVLT in addition to the standard multimodal analgesia. P-IVLT will consist of 1 mg/kg bolus at start of anesthesia (T0), followed by 2 mg·kg-1·hr-1 infusion for 8 hours (T1), then continued at 1 mg·kg-1·hr-1 infusion thereafter and postoperatively until T0 + 48 hours (T2).<br>|
| Placebo Comparator: Intravenous saline control<br>0.9% sodium chloride, also known as normal saline | Drug: Saline Solution<br>* Control group (B) will receive a placebo (0.9% sodium chloride also known as normal saline), made to mimic the intervention protocol described above, in addition to the standard multimodal analgesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine utilization | Documented from acute pain service charts (mg/kg) | 48 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine utilization | Documented from acute pain service charts (mg/kg) | 12, 24, 36 hours post-operatively | 
| Postoperative pain | Pain scores measured every 4 hours by nursing staff | from emergence in the anesthetic care unit through 48 hours post-operatively | 
| Mobililzation | Time from anesthesia induction to first walk of greater than 15 steps (hours) | through hospital stay, an average of 5 days | 
| Urinary incontinence | Time from anesthesia induction to urinary catheter removal (hours) | through hospital stay, an average of 5 days | 
| Postoperative pain (II) | Time from anesthesia induction to termination of morphine (hours) | through study completion, 48 hours post-operatively | 
| Recovery | Time from anesthesia induction to discharge from hospital (days) | through hospital stay, an average of 5 days |