IV Lidocaine Analgesia in Pediatric Scoliosis Surgery

Scoliosis; Adolescence Clinical Trial

— P-IVLT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04069169
• Other study ID #: H18-03103
• Status: Recruiting
• Phase: Phase 3
• Start date: December 18, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of British Columbia
• Contact: Steffanie Fisher, MSc
• Phone: 604-875-2000
• Email: steffanie.fisher[@]bcchr.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Recovery Period
• Scoliosis
• Scoliosis; Adolescence

Intervention

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).
• 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.

Locations

Country	Name	City	State
Canada	BC Children's Hospital - Department of Anesthesia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

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

External Links

•   Pediatric Anesthesia Research Team website