IV Lidocaine Analgesia in Pediatric Scoliosis Surgery

NCT04069169 | Completed Phase 3 DMC

• 1 other identifier: H18-03103
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Adolescence; Anesthesia Recovery Period

Outcome Measures

Primary Outcomes (1)

• Total morphine utilization

  Documented from acute pain service charts (mg/kg)

  48 hours post-operatively

Secondary Outcomes (6)

• Total morphine utilization

  12, 24, 36 hours post-operatively

• Postoperative pain

  from emergence in the anesthetic care unit through 48 hours post-operatively

• Mobililzation

  through hospital stay, an average of 5 days

• Urinary incontinence

  through hospital stay, an average of 5 days

• Postoperative pain (II)

  through study completion, 48 hours post-operatively

Study Arms (2)

Intravenous lidocaine

EXPERIMENTAL

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

Drug: Lidocaine

Intravenous saline control

PLACEBO COMPARATOR

0.9% sodium chloride, also known as normal saline

Drug: Saline Solution

Interventions

Lidocaine DRUG

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).

Intravenous lidocaine

Saline Solution DRUG

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.

Intravenous saline control

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital - Department of Anesthesia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (1)

• Luo J, West N, Pang S, Golam A, Adams E, Gorges M, Carr RR, Miyanji F, Lauder GR. Perioperative Intravenous Lidocaine Infusion Therapy as an Adjunct to Multimodal Analgesia for Adolescent Idiopathic Scoliosis Surgical Correction: A Double-Blind Randomized Controlled Trial. Paediatr Anaesth. 2025 Jul;35(7):552-561. doi: 10.1111/pan.15124. Epub 2025 May 6.

  PMID: 40326715 DERIVED

Related Links

• Pediatric Anesthesia Research Team website

MeSH Terms

Conditions

Scoliosis

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gill Lauder, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Following receipt of informed consent, participants will be randomized by the Pharmacy Research Support Pharmacist. Pharmacy research staff will prepare an appropriate randomization schedule (patients randomized to P-IVLT or control) and deploy blinded study drug to the operating room, anesthesia care unit, and post-surgical ward as required. Unless emergency unblinding is required, the following people will remain blinded to group allocation until the full cohort has been recruited and data collection has been completed: 1. All anesthesia, APS, nursing, clinical pharmacists and surgical staff involved in the patient's clinical care 2. The patient and their family 3. Research staff involved in recruitment and data collection
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: August 28, 2019
• Study Start: December 18, 2019
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)