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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069169
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Gillian Lauder, University of British Columbia

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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:

  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
Official Title: Perioperative Multimodal Analgesia Including Intravenous Lidocaine Infusion for Pain Management Following Idiopathic Scoliosis Correction Surgery in Children
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Total morphine utilization [ Time Frame: 48 hours post-operatively ]
    Documented from acute pain service charts (mg/kg)


Secondary Outcome Measures :
  1. Total morphine utilization [ Time Frame: 12, 24, 36 hours post-operatively ]
    Documented from acute pain service charts (mg/kg)

  2. 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

  3. Mobililzation [ Time Frame: through hospital stay, an average of 5 days ]
    Time from anesthesia induction to first walk of greater than 15 steps (hours)

  4. Urinary incontinence [ Time Frame: through hospital stay, an average of 5 days ]
    Time from anesthesia induction to urinary catheter removal (hours)

  5. Postoperative pain (II) [ Time Frame: through study completion, 48 hours post-operatively ]
    Time from anesthesia induction to termination of morphine (hours)

  6. Recovery [ Time Frame: through hospital stay, an average of 5 days ]
    Time from anesthesia induction to discharge from hospital (days)



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069169


Contacts
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Contact: Andrew Poznikoff, BSc 604-875-2000 ext 1989 andrew.poznikoff@cw.bc.ca

Locations
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Canada, British Columbia
BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Andrew Poznikoff, BSc    604-875-2000 ext 1989    andrew.poznikoff@cw.bc.ca   
Principal Investigator: Gill Lauder, MD         
Sub-Investigator: Firoz Miyanji, MD         
Sub-Investigator: Roxanne Carr, PharmD         
Sub-Investigator: Nicolas West, MSc         
Sub-Investigator: Andrew Poznikoff, BSc         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Gill Lauder, MD University of British Columbia
Additional Information:
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Responsible Party: Gillian Lauder, Staff Anesthesiologist, University of British Columbia
ClinicalTrials.gov Identifier: NCT04069169    
Other Study ID Numbers: H18-03103
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action