Adolescent Idiopathic ScoliosisPhase 4AIMSNCT05730920
IV Methadone Vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction
A Phase 4 study testing Methadone and Liposomal bupivacaine (LB, Exparel) in people with Adolescent Idiopathic Scoliosis and Juvenile Idiopathic Scoliosis, run by Dr. Casey Stondell, MD at 1 site in United States.
Trial summary
The goal of this pilot study is to assess the feasibility of conducting a randomized controlled trial at a single institution comparing erector spinae plane blockade (ESPB) with liposomal bupivacaine (LB, Exparel) to intravenous (IV) methadone for managing pain in pediatric subjects undergoing adolescent and juvenile… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Juvenile Idiopathic Scoliosis
- What is being tested?
- Methadone and Liposomal bupivacaine (LB, Exparel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2022to 21 Sep 2024
- Phase
- Phase 4
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects whose parent(s) or guardian(s) has/have signed and dated the informed consent form (ICF) for the subject to participate in the study
- Patients with a diagnosis of juvenile idiopathic scoliosis (JIS) or adolescent idiopathic scoliosis (AIS) who will have posterior spinal fusion surgery
- Male or female patients 11 to less than 18 years of age on the day of surgery.
- American Society of Anesthesiologists (ASA) Class 1-2.
- Able to adhere to the study visit schedule and complete all study assessments.
Who cannot join
- Body mass index ≥35 at the time of screening
- Contraindication to regional anesthesia (e.g., abnormal coagulation, infection at site)
- Current opioid use at the time of screening
- Current diagnosis of chronic pain
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications
- Administration of liposomal bupivacaine (LB, Exparel)
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- Subject/parent/guardian primary language other than English or Spanish
- Inability of patient to verbally express symptoms such as pain and side effects (as in moderate to severe developmental delay)
- A prolonged QTc on preoperative EKG (QTc longer than 450 milliseconds)
- History of Torsades de Pointes
- Renal or hepatic impairment
- Diagnosed active seizure disorder
- Any other condition that causes patient to be ineligible for surgery, i.e. pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Sacramento, California, 95817
About this study
Official title: A Single-center, Randomized, Single-blind Pilot Study to Evaluate Intravenous Methadone Versus EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Adolescent and Juvenile Idiopathic Scoliosis Correction
The goal of this pilot study is to assess the feasibility of conducting a randomized controlled trial at a single institution comparing erector spinae plane blockade (ESPB) with liposomal bupivacaine (LB, Exparel) to intravenous (IV) methadone for managing pain in pediatric subjects undergoing adolescent and juvenile idiopathic scoliosis correction. Specifically, the goal is to enroll 15 subjects in each group and to complete data collection for all subjects. If this pilot study is successful, we plan to then design a larger scale study powered to compare specific outcomes between the two groups.
Read the detailed description
Enrolled subjects will be randomized to one of two groups: one group will receive intra-operative IV methadone as the primary means of controlling post-operative pain while the other group will instead receive intra-operative erector spinae plane blocks (ESPB) with liposomal bupivacaine (LB, Exparel) and bupivacaine hydrochloride as the primary means of controlling postoperative pain. All other aspects of peri-operative management will be standardized. Subjects and the post-operative care team will be blinded to which intervention was performed in order to reduce bias. Upon discharge, subjects will receive a wearable activity monitor and a daily journal in order to record post-discharge data. Subjects will receive weekly phone calls for data collection and then will have a final in-person clinic visit, at which point participation in the study will conclude.
- Being tested
- Methadone, Liposomal bupivacaine (LB, Exparel)
- Keywords
- scoliosis, methadone, exparel, regional anesthesia, erector spinae plane block, pediatric
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
IV Methadone
Liposomal bupivacaine (LB, Exparel)Drug
LB and bupivacaine hydrochloride via erector spinae plane blocks
| Study group | Role | What they receive |
|---|---|---|
| Intravenous (IV) Methadone | Active comparator | Subjects will receive IV methadone 0.2 mg/kg (maximum dose 20mg) via an infusion pump over 15 minutes while undergoing continuous monitoring. Additional IV methadone may be given during the case per the anesthesiologist's discretion, but the total dose may not exceed 20mg. Receives: Drug: Methadone |
| Liposomal Bupivacaine (LB, Exparel) | Experimental | Subjects will receive four-point ESPB with an admixture of LB and 0.25% bupivacaine hydrochloride. The total LB dose will be 4mg/kg, max dose of 266mg, while the total dose of bupivacaine hydrochloride will be 2mg/kg. Receives: Drug: Liposomal bupivacaine (LB, Exparel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Enrollment and Data Collection of 30 Subjects
Assess the feasibility of completing a prospective randomized trial pilot study comparing Erector Spinae Plane Blockade (ESPB) with liposomal bupivacaine (LB) to intravenous methadone at a single institution in two years
Measured: 2 years
Secondary outcomes (3)
Opioid Consumption
Assess whether there is a difference in post-operative opioid consumption between the two study groups. This will evaluated by converting all long-acting opioids to daily morphine equivalents per unit of weight.
Measured: 2 years
Pain Scores
Assess whether there is a difference in post-operative pain scores between the two study groups. Visual analog scale (VAS) scores with a minimum of 0 and a maximum of 10 will be used where 0 is no pain and 10 is the worst pain imaginable
Measured: 2 years
Length of Stay
Assess whether there is a difference in hospital length of stay between the two study groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start19 Oct 2022
- Primary completion16 Jul 2024
- Study completion21 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Casey Stondell, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor-investigator, Dr. Casey Stondell, MD, Shriners Hospitals for Children
- Investigators
- Casey Stondell, MD, Principal investigator, Shriners Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730920
- Sponsor's protocol ID
- NCA2205
- Acronym
- AIMS
- Status last verified
- Oct 2024
- First submitted
- 25 Jan 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Single-blind Pilot Study to Evaluate Intravenous Methadone Versus EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Adolescent and Juvenile Idiopathic Scoliosis Correction
- ClinicalTrials.gov ID
- NCT05730920
- Acronym / sponsor ID
- AIMS / NCA2205
- Keywords
- scoliosis, methadone, exparel, regional anesthesia, erector spinae plane block, pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Casey Stondell, MDUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 21 Sep 2024 (actual)
- First posted
- 16 Feb 2023 (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.
The goal of this pilot study is to assess the feasibility of conducting a randomized controlled trial at a single institution comparing erector spinae plane blockade (ESPB) with liposomal bupivacaine (LB, Exparel) to intravenous (IV) methadone for managing pain in pediatric subjects undergoing adolescent and juvenile idiopathic scoliosis correction. Specifically, the goal is to enroll 15 subjects in each group and to complete data collection for all subjects. If this pilot study is successful, we plan to then design a larger scale study powered to compare specific outcomes between the two groups.
Detailed description
Enrolled subjects will be randomized to one of two groups: one group will receive intra-operative IV methadone as the primary means of controlling post-operative pain while the other group will instead receive intra-operative erector spinae plane blocks (ESPB) with liposomal bupivacaine (LB, Exparel) and bupivacaine hydrochloride as the primary means of controlling postoperative pain. All other aspects of peri-operative management will be standardized. Subjects and the post-operative care team will be blinded to which intervention was performed in order to reduce bias. Upon discharge, subjects will receive a wearable activity monitor and a daily journal in order to record post-discharge data. Subjects will receive weekly phone calls for data collection and then will have a final in-person clinic visit, at which point participation in the study will conclude.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous (IV) Methadone | Active comparator | Drug: MethadoneSubjects will receive IV methadone 0.2 mg/kg (maximum dose 20mg) via an infusion pump over 15 minutes while undergoing continuous monitoring. Additional IV methadone may be given during the case per the anesthesiologist's discretion, but the total dose may not exceed 20mg. |
| Liposomal Bupivacaine (LB, Exparel) | Experimental | Drug: Liposomal bupivacaine (LB, Exparel)Subjects will receive four-point ESPB with an admixture of LB and 0.25% bupivacaine hydrochloride. The total LB dose will be 4mg/kg, max dose of 266mg, while the total dose of bupivacaine hydrochloride will be 2mg/kg. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects whose parent(s) or guardian(s) has/have signed and dated the informed consent form (ICF) for the subject to participate in the study
- Patients with a diagnosis of juvenile idiopathic scoliosis (JIS) or adolescent idiopathic scoliosis (AIS) who will have posterior spinal fusion surgery
- Male or female patients 11 to less than 18 years of age on the day of surgery.
- American Society of Anesthesiologists (ASA) Class 1-2.
- Able to adhere to the study visit schedule and complete all study assessments.
Key exclusion criteria (13 listed)
- Body mass index ≥35 at the time of screening
- Contraindication to regional anesthesia (e.g., abnormal coagulation, infection at site)
- Current opioid use at the time of screening
- Current diagnosis of chronic pain
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications
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 |
|---|---|---|
| MethadoneIV Methadone | Drug | Intravenous (IV) Methadone |
| Liposomal bupivacaine (LB, Exparel)LB and bupivacaine hydrochloride via erector spinae plane blocks | Drug | Liposomal Bupivacaine (LB, Exparel) |
Primary outcome
Successful Enrollment and Data Collection of 30 Subjects
Time frame: 2 years
Assess the feasibility of completing a prospective randomized trial pilot study comparing Erector Spinae Plane Blockade (ESPB) with liposomal bupivacaine (LB) to intravenous methadone at a single institution in two years
3 secondary outcomes
Opioid Consumption
Time frame: 2 years
Pain Scores
Time frame: 2 years
Length of Stay
Time frame: 2 years
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 4 Oct 2024.
- 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.
Casey Stondell, MD principal investigator
Shriners Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone and Liposomal bupivacaine (LB, Exparel) in people with Adolescent Idiopathic Scoliosis and Juvenile Idiopathic Scoliosis, run by Dr. Casey Stondell, MD at 1 site in United States.
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 5 inclusion and 13 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 4 Oct 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 United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Successful Enrollment and Data Collection of 30 Subjects (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2024.