IV Lidocaine Analgesia in Pediatric Scoliosis Surgery (P-IVLT)
Primary Purpose
Scoliosis; Adolescence, Anesthesia Recovery Period
Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine
Saline Solution
Sponsored by
About this trial
This is an interventional supportive care trial for Scoliosis; Adolescence
Eligibility Criteria
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
Sites / Locations
- BC Children's Hospital - Department of AnesthesiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intravenous lidocaine
Intravenous saline control
Arm Description
1% preservative free lidocaine 10 mg/ml in 0.9% NaCl
0.9% sodium chloride, also known as normal saline
Outcomes
Primary Outcome Measures
Total morphine utilization
Documented from acute pain service charts (mg/kg)
Secondary Outcome Measures
Total morphine utilization
Documented from acute pain service charts (mg/kg)
Postoperative pain
Pain scores measured every 4 hours by nursing staff
Mobililzation
Time from anesthesia induction to first walk of greater than 15 steps (hours)
Urinary incontinence
Time from anesthesia induction to urinary catheter removal (hours)
Postoperative pain (II)
Time from anesthesia induction to termination of morphine (hours)
Recovery
Time from anesthesia induction to discharge from hospital (days)
Full Information
NCT ID
NCT04069169
First Posted
May 13, 2019
Last Updated
May 12, 2023
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04069169
Brief Title
IV Lidocaine Analgesia in Pediatric Scoliosis Surgery
Acronym
P-IVLT
Official Title
Perioperative Multimodal Analgesia Including Intravenous Lidocaine Infusion for Pain Management Following Idiopathic Scoliosis Correction Surgery in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis; Adolescence, Anesthesia Recovery Period
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravenous lidocaine
Arm Type
Experimental
Arm Description
1% preservative free lidocaine 10 mg/ml in 0.9% NaCl
Arm Title
Intravenous saline control
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride, also known as normal saline
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total morphine utilization
Description
Documented from acute pain service charts (mg/kg)
Time Frame
48 hours post-operatively
Secondary Outcome Measure Information:
Title
Total morphine utilization
Description
Documented from acute pain service charts (mg/kg)
Time Frame
12, 24, 36 hours post-operatively
Title
Postoperative pain
Description
Pain scores measured every 4 hours by nursing staff
Time Frame
from emergence in the anesthetic care unit through 48 hours post-operatively
Title
Mobililzation
Description
Time from anesthesia induction to first walk of greater than 15 steps (hours)
Time Frame
through hospital stay, an average of 5 days
Title
Urinary incontinence
Description
Time from anesthesia induction to urinary catheter removal (hours)
Time Frame
through hospital stay, an average of 5 days
Title
Postoperative pain (II)
Description
Time from anesthesia induction to termination of morphine (hours)
Time Frame
through study completion, 48 hours post-operatively
Title
Recovery
Description
Time from anesthesia induction to discharge from hospital (days)
Time Frame
through hospital stay, an average of 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steffanie Fisher, MSc
Phone
604-875-2000
Ext
1989
Email
steffanie.fisher@bcchr.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gill Lauder, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's Hospital - Department of Anesthesia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steffanie Fisher, MSc
Phone
604-875-2000
Ext
1989
Email
steffanie.fisher@bcchr.ca
First Name & Middle Initial & Last Name & Degree
Gill Lauder, MD
First Name & Middle Initial & Last Name & Degree
Firoz Miyanji, MD
First Name & Middle Initial & Last Name & Degree
Roxanne Carr, PharmD
First Name & Middle Initial & Last Name & Degree
Nicolas West, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://bcchr.ca/PART
Description
Pediatric Anesthesia Research Team website
Learn more about this trial
IV Lidocaine Analgesia in Pediatric Scoliosis Surgery
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