Scoliosis; AdolescencePhase 3P-IVLTNCT04069169
IV Lidocaine Analgesia in Pediatric Scoliosis Surgery
A Phase 3 study testing Lidocaine and Saline Solution in people with Scoliosis; Adolescence and Anesthesia Recovery Period, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Scoliosis; Adolescence, Anesthesia Recovery Period
- What is being tested?
- Lidocaine and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 18 Dec 2019to 10 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA I-III
- Diagnosed with Idiopathic scoliosis
- Undergoing single-stage posterior spinal instrumentation and fusion
Who cannot join
- Thorascopic tethering procedure
- Two-stage procedure
- Abnormal developmental profile
- Congenital/neuromuscular scoliosis
- Requiring PICU admission
- Known allergy to lidocaine
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Perioperative Multimodal Analgesia Including Intravenous Lidocaine Infusion for Pain Management Following Idiopathic Scoliosis Correction Surgery in Children
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.
Read the 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.
- Conditions
- Scoliosis; Adolescence, Anesthesia Recovery Period
- Being tested
- Lidocaine, Saline Solution
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
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 SolutionDrug
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 group | Role | What they receive |
|---|---|---|
| Intravenous lidocaine | Experimental | 1% preservative free lidocaine 10 mg/ml in 0.9% NaCl Receives: Drug: Lidocaine |
| Intravenous saline control | Placebo comparator | 0.9% sodium chloride, also known as normal saline Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine utilization
Documented from acute pain service charts (mg/kg)
Measured: 48 hours post-operatively
Secondary outcomes (6)
Total morphine utilization
Documented from acute pain service charts (mg/kg)
Measured: 12, 24, 36 hours post-operatively
Postoperative pain
Pain scores measured every 4 hours by nursing staff
Measured: 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)
Measured: through hospital stay, an average of 5 days
Urinary incontinence
Time from anesthesia induction to urinary catheter removal (hours)
Measured: through hospital stay, an average of 5 days
Postoperative pain (II)
Time from anesthesia induction to termination of morphine (hours)
Measured: through study completion, 48 hours post-operatively
Recovery
Time from anesthesia induction to discharge from hospital (days)
Measured: through hospital stay, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start18 Dec 2019
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gillian Lauder, University of British Columbia
- Investigators
- Gill Lauder, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069169
- Sponsor's protocol ID
- H18-03103
- Acronym
- P-IVLT
- Status last verified
- May 2024
- First submitted
- 13 May 2019
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40326715
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Multimodal Analgesia Including Intravenous Lidocaine Infusion for Pain Management Following Idiopathic Scoliosis Correction Surgery in Children
- ClinicalTrials.gov ID
- NCT04069169
- Acronym / sponsor ID
- P-IVLT / H18-03103
- Conditions
- Scoliosis; Adolescence, Anesthesia Recovery Period
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine | Experimental | Drug: Lidocaine1% preservative free lidocaine 10 mg/ml in 0.9% NaCl |
| Intravenous saline control | Placebo comparator | Drug: Saline Solution0.9% sodium chloride, also known as normal saline |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ASA I-III
- Diagnosed with Idiopathic scoliosis
- Undergoing single-stage posterior spinal instrumentation and fusion
Key exclusion criteria (14 listed)
- Thorascopic tethering procedure
- Two-stage procedure
- Abnormal developmental profile
- Congenital/neuromuscular scoliosis
- Requiring PICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineIntervention 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 | Intravenous lidocaine |
| Saline SolutionControl 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. | Drug | Intravenous saline control |
Primary outcome
Total morphine utilization
Time frame: 48 hours post-operatively
Documented from acute pain service charts (mg/kg)
6 secondary outcomes
Total morphine utilization
Time frame: 12, 24, 36 hours post-operatively
Postoperative pain
Time frame: from emergence in the anesthetic care unit through 48 hours post-operatively
Mobililzation
Time frame: through hospital stay, an average of 5 days
Urinary incontinence
Time frame: through hospital stay, an average of 5 days
Postoperative pain (II)
Time frame: through study completion, 48 hours post-operatively
Recovery
Time frame: through hospital stay, an average of 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 40326715Luo 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.
- Pediatric Anesthesia Research Team websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gill Lauder, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine and Saline Solution in people with Scoliosis; Adolescence and Anesthesia Recovery Period, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine utilization (time frame: 48 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04069169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.