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IV Lidocaine Analgesia in Pediatric Scoliosis Surgery (P-IVLT)

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ClinicalTrials.gov Identifier: NCT04069169
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Gillian Lauder, University of British Columbia

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date July 27, 2020
Actual Study Start Date  ICMJE December 18, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
Total morphine utilization [ Time Frame: 48 hours post-operatively ]
Documented from acute pain service charts (mg/kg)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
  • Total morphine utilization [ Time Frame: 12, 24, 36 hours post-operatively ]
    Documented from acute pain service charts (mg/kg)
  • Postoperative pain [ Time Frame: from emergence in the anesthetic care unit through 48 hours post-operatively ]
    Pain scores measured every 4 hours by nursing staff
  • Mobililzation [ Time Frame: through hospital stay, an average of 5 days ]
    Time from anesthesia induction to first walk of greater than 15 steps (hours)
  • Urinary incontinence [ Time Frame: through hospital stay, an average of 5 days ]
    Time from anesthesia induction to urinary catheter removal (hours)
  • Postoperative pain (II) [ Time Frame: through study completion, 48 hours post-operatively ]
    Time from anesthesia induction to termination of morphine (hours)
  • Recovery [ Time Frame: through hospital stay, an average of 5 days ]
    Time from anesthesia induction to discharge from hospital (days)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IV Lidocaine Analgesia in Pediatric Scoliosis Surgery
Official Title  ICMJE Perioperative Multimodal Analgesia Including Intravenous Lidocaine Infusion for Pain Management Following Idiopathic Scoliosis Correction Surgery in Children
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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:

  1. 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.
  2. 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:

  1. All anesthesia, APS, nursing, clinical pharmacists and surgical staff involved in the patient's clinical care
  2. The patient and their family
  3. Research staff involved in recruitment and data collection
Primary Purpose: Supportive Care
Condition  ICMJE
  • Scoliosis; Adolescence
  • Anesthesia Recovery Period
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Intravenous lidocaine
    1% preservative free lidocaine 10 mg/ml in 0.9% NaCl
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Intravenous saline control
    0.9% sodium chloride, also known as normal saline
    Intervention: Drug: Saline Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2019)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrew Poznikoff, BSc 604-875-2000 ext 1989 andrew.poznikoff@cw.bc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04069169
Other Study ID Numbers  ICMJE H18-03103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gillian Lauder, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gill Lauder, MD University of British Columbia
PRS Account University of British Columbia
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP