IV Lidocaine Analgesia in Pediatric Scoliosis Surgery (P-IVLT)

University of British Columbia

Status and phase: Completed; Phase 3

Conditions: Anesthesia Recovery Period; Scoliosis; Adolescence

Treatments: Drug: Lidocaine; Drug: Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04069169

H18-03103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 10 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

48 participants in 2 patient groups, including a placebo group

Intravenous lidocaine

Experimental group

Description:

1% preservative free lidocaine 10 mg/ml in 0.9% NaCl

Treatment:

Drug: Lidocaine

Intravenous saline control

Placebo Comparator group

Description:

0.9% sodium chloride, also known as normal saline

Treatment:

Drug: Saline Solution