Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-02 @ 12:25 AM
Study NCT ID:
NCT04069169
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2019-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IV Lidocaine Analgesia in Pediatric Scoliosis Surgery
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Perioperative Multimodal Analgesia Including Intravenous Lidocaine Infusion for Pain Management Following Idiopathic Scoliosis Correction Surgery in Children
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P-IVLT
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: