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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous lidocaine | Experimental | 1% preservative free lidocaine 10 mg/ml in 0.9% NaCl |
|
| Intravenous saline control | Placebo Comparator | 0.9% sodium chloride, also known as normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine utilization | Documented from acute pain service charts (mg/kg) | 48 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine utilization | Documented from acute pain service charts (mg/kg) | 12, 24, 36 hours post-operatively |
| Postoperative pain | Pain scores measured every 4 hours by nursing staff |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gill Lauder, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital - Department of Anesthesia | Vancouver | British Columbia | V6H 3V4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40326715 | Derived | Luo J, West N, Pang S, Golam A, Adams E, Gorges M, Carr RR, Miyanji F, Lauder GR. Perioperative Intravenous Lidocaine Infusion Therapy as an Adjunct to Multimodal Analgesia for Adolescent Idiopathic Scoliosis Surgical Correction: A Double-Blind Randomized Controlled Trial. Paediatr Anaesth. 2025 Jul;35(7):552-561. doi: 10.1111/pan.15124. Epub 2025 May 6. |
| Label | URL |
|---|---|
| Pediatric Anesthesia Research Team website | View source |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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:
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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:
|
| Saline Solution | Drug | 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. |
|
| from emergence in the anesthetic care unit through 48 hours post-operatively |
| Mobililzation | Time from anesthesia induction to first walk of greater than 15 steps (hours) | through hospital stay, an average of 5 days |
| Urinary incontinence | Time from anesthesia induction to urinary catheter removal (hours) | through hospital stay, an average of 5 days |
| Postoperative pain (II) | Time from anesthesia induction to termination of morphine (hours) | through study completion, 48 hours post-operatively |
| Recovery | Time from anesthesia induction to discharge from hospital (days) | through hospital stay, an average of 5 days |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |