P-IVLT: IV Lidocaine Analgesia in Pediatric Scoliosis Surgery

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04069169

Collaborator

(none)

Enrollment

Location

Arms

35.4

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis; Adolescence Anesthesia Recovery Period	Drug: Lidocaine Drug: Saline Solution	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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: 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. Control group will receive a placebo (0.9% sodium chloride also known as normal saline), made to mimic the intervention.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: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. Control group will receive a placebo (0.9% sodium chloride also known as normal saline), made to mimic the intervention.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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: All anesthesia, APS, nursing, clinical pharmacists and surgical staff involved in the patient's clinical care The patient and their family Research staff involved in recruitment and data collection

Primary Purpose:

Supportive Care

Official Title:

Perioperative Multimodal Analgesia Including Intravenous Lidocaine Infusion for Pain Management Following Idiopathic Scoliosis Correction Surgery in Children

Actual Study Start Date :

Dec 18, 2019

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravenous lidocaine 1% preservative free lidocaine 10 mg/ml in 0.9% NaCl	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).
Placebo Comparator: Intravenous saline control 0.9% sodium chloride, also known as normal saline	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.

Arm

Intervention/Treatment

Experimental: Intravenous lidocaine

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

Drug: Lidocaine

Placebo Comparator: Intravenous saline control

0.9% sodium chloride, also known as normal saline

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.

Outcome Measures

Primary Outcome Measures

Total morphine utilization [48 hours post-operatively]
Documented from acute pain service charts (mg/kg)

Secondary Outcome Measures

Total morphine utilization [12, 24, 36 hours post-operatively]
Documented from acute pain service charts (mg/kg)
Postoperative pain [from emergence in the anesthetic care unit through 48 hours post-operatively]
Pain scores measured every 4 hours by nursing staff
Mobililzation [through hospital stay, an average of 5 days]
Time from anesthesia induction to first walk of greater than 15 steps (hours)
Urinary incontinence [through hospital stay, an average of 5 days]
Time from anesthesia induction to urinary catheter removal (hours)
Postoperative pain (II) [through study completion, 48 hours post-operatively]
Time from anesthesia induction to termination of morphine (hours)
Recovery [through hospital stay, an average of 5 days]
Time from anesthesia induction to discharge from hospital (days)

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 19 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BC Children's Hospital - Department of Anesthesia	Vancouver	British Columbia	Canada	V6H 3V4

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator: Gill Lauder, MD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Pediatric Anesthesia Research Team website

Publications

None provided.

Responsible Party:

Gillian Lauder, Staff Anesthesiologist, University of British Columbia

ClinicalTrials.gov Identifier:

NCT04069169

Other Study ID Numbers:

H18-03103

First Posted:

Aug 28, 2019

Last Update Posted:

Oct 6, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Scoliosis

Lidocaine

Study Results

No Results Posted as of Oct 6, 2021