Clinical trial NCT04069169: IV Lidocaine Analgesia in Pediatric Scoliosis Surgery
Official title: Perioperative Multimodal Analgesia Including Intravenous Lidocaine Infusion for Pain Management Following Idiopathic Scoliosis Correction Surgery in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scoliosis; Adolescence
Anesthesia Recovery Period
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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:

1. 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.
2. Control group will receive a placebo (0.9% sodium chloride also known as normal saline), made to mimic the intervention.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total morphine utilization
timeFrame: 48 hours post-operatively
Secondary outcomes:
measure: Total morphine utilization
timeFrame: 12, 24, 36 hours post-operatively
measure: Postoperative pain
timeFrame: from emergence in the anesthetic care unit through 48 hours post-operatively
measure: Mobililzation
timeFrame: through hospital stay, an average of 5 days
measure: Urinary incontinence
timeFrame: through hospital stay, an average of 5 days
measure: Postoperative pain (II)
timeFrame: through study completion, 48 hours post-operatively
measure: Recovery
timeFrame: through hospital stay, an average of 5 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital - Department of Anesthesia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Gill Lauder, MD
role: PRINCIPAL_INVESTIGATOR
References: