IV Lidocaine Analgesia in Pediatric Scoliosis Surgery

Phase

Condition

N/A

Treatment

Saline Solution

Lidocaine

Clinical Study ID

NCT04069169

H18-03103

Ages 10-19
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

ASA I-III
Diagnosed with Idiopathic scoliosis
Undergoing single-stage posterior spinal instrumentation and fusion

Exclusion

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, definedaccording 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

Study Design

Saline Solution

December 18, 2019

May 10, 2024

Study Description

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.

Connect with a study center

BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia V6H 3V4
Canada
Site Not Available

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