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IV Lidocaine Analgesia in Pediatric Scoliosis Surgery

NCT04069169 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-05-14

No results posted yet for this 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.

Conditions

  • Scoliosis; Adolescence
  • Anesthesia Recovery Period

Interventions

DRUG

Lidocaine

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).

DRUG

Saline Solution

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.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Gill Lauder, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2024-05-10
Completion
2024-05-10

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069169 on ClinicalTrials.gov