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NCT04069169: P-IVLT

IV Lidocaine Analgesia in Pediatric Scoliosis Surgery

Completed Phase 3 Last updated 14 May 2024
What this trial tests

Phase 3 trial testing Lidocaine in Scoliosis; Adolescence in 48 participants. Completed in 10 May 2024.

Timeline
18 December 2019
Primary endpoint
10 May 2024
10 May 2024

Quick facts

Lead sponsorUniversity of British Columbia
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposesupportive care
Enrollment48
Start date18 December 2019
Primary completion10 May 2024
Estimated completion10 May 2024
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of British Columbia

Who can join

Adults 10 to 19, any sex, with Scoliosis; Adolescence or Anesthesia Recovery Period. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Perioperative Intravenous Lidocaine Infusion Therapy as an Adjunct to Multimodal Analgesia for Adolescent Idiopathic Scoliosis Surgical Correction: A Double-Blind Randomized Controlled Trial.
    Luo J, West N, Pang S, Golam A, et al · · 2025 · PMID 40326715 · DOI 10.1111/pan.15124

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Other trials of Lidocaine

Trials testing the same drug.

Other recruiting trials for Scoliosis; Adolescence

Currently open trials in the same condition.

Other University of British Columbia trials

Trials by the same sponsor.

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Data sources for this page

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