Adolescent Idiopathic Scoliosis (AIS)Phase 4NCT06935331
Prospective Opioid-Free AIS Fusion
A Phase 4 study testing Opioid-Free/Opioid-Avoidant and Opioid-Containing in people with Adolescent Idiopathic Scoliosis (AIS), run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of a multimodal opioid-free (OF) pain management protocol with a traditional opioid-containing (OC) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- Opioid-Free/Opioid-Avoidant and Opioid-Containing
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients (10-20 years of age at the time of surgery)
- Diagnosis of idiopathic scoliosis
- Undergoing primary instrumented PSF
Who cannot join
- Age <10 years or >20 years at time of surgery
- Patients with non-idiopathic scoliosis etiology, ie neuromuscular or syndromic scoliosis
- Patients undergoing non-fusion spinal surgeries, ie growing rods or tethering
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
About this study
Official title: Comparison of Opioid-Free Versus Traditional Opioid-Containing Postoperative Pain Management Pathways for Adolescent Idiopathic Scoliosis
The purpose of this study is to compare the efficacy of a multimodal opioid-free (OF) pain management protocol with a traditional opioid-containing (OC) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis.
Read the detailed description
Opioids are the most common controlled medication used medically and non-medically by adolescents in the United States. Opioid prescribing practices are inextricably linked with the ongoing public health crisis of opioid misuse in the peri-adolescent population. However, the immediate postoperative period following instrumented posterior spinal fusion (PSF) for idiopathic scoliosis represents a difficult challenge for patients and surgeons alike - particularly with regard to pain control. Opioid medications are commonly used to manage early postoperative pain in these patients, though are associated with potentially deleterious effects and remain at the center of a national health crisis. In particular for peri-adolescent patients, opioids are known to disrupt central nervous system maturation, which may lead to long-term behavioral dysfunction, including increased vulnerability to addiction in adulthood. On the other hand, it is well-recognized that inadequate pain control is associated with atelectasis, delayed mobilization, protracted hospitalization, and increased complication rates following posterior instrumented PSF for idiopathic scoliosis. Consequently, there is a rising, unmet need to develop postoperative recovery pathways for this population, aimed at efficient and safe pain management that minimizes or eliminates opioids while ensuring a positive postoperative experience for the patient.
Previous studies in adult and pediatric patients have compared traditional opioid-based pain regimens to opioid-sparing regimens in the perioperative period, but have been limited by high rates of crossover, retrospective designs, reliance on indwelling pain catheters, reliance on opioids for early postoperative analgesia, and/or lack of patient-reported outcomes. While there are growing efforts to investigate and adopt opioid-free (OF) protocols in adult orthopaedic patients, such protocols have yet to be thoroughly evaluated in the pediatric population. A prior study approved and completed (Protocol# PED032) by Dr. Michael Paloski and team demonstrated that a comprehensive, multimodal, OF pain management pathway following instrumented PSF for idiopathic scoliosis results in equivalent length of stay and fewer opioids prescribed at discharge compared with a traditional opioid-containing (OC) pathway. To our knowledge, this was the first study to show that completely OF postoperative pain management is possible in this population. Additional studies, including the study proposed here, are necessary to evaluate patient-reported outcomes in this population when OF pain management is utilized and to delineate patient-specific and procedure-specific details that may predict success with an OF regimen.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- Opioid-Free/Opioid-Avoidant, Opioid-Containing
- Keywords
- Adolescent Idiopathic Scoliosis (AIS), Opioid, Pain Management Pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-Free/Opioid-AvoidantDrug
Managed post-operatively with an opioid-free pain regimen which will include:
Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound
Gabapentin PO 300 mg TID x 30 days
Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours
Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs
Acetaminophen PO dosed per body weight and discharged home with PO tabs
Diazepam PO dosed per body weight during stay and discharged home with PO tabs
Non-medicinal therapy: Ice, Aromatherapy, Music therapy, Pet therapy, Early mobilization and PT
Opioid-ContainingDrug
Managed post-operatively with a traditional opioid containing pain regimen including:
Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound
Post-operative morphine IV for breakthrough pain
Oral narcotic (hydrocodone/acetaminophen)
Gabapentin PO 300 mg TID x 30 days
Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours
Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs
Acetaminophen PO dosed per body weight and discharged home with PO tabs
Diazepam PO dosed per body weight during stay and discharged home with PO tabs
Non-medicinal therapy: Ice, Early mobilization and PT
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Free/Opioid-Avoidant | Experimental | Managed post-operatively with an opioid-free pain regimen which will include:
Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound.
Gabapentin PO 300 mg TID x 30 days.
Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours.
Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs.
Acetaminophen PO dosed per body weight and discharged home with PO tabs.
Diazepam PO dosed per body weight during stay and discharged home with PO tabs.
Non-medicinal therapy: Ice, Aromatherapy, Music therapy, Pet therapy, Early mobilization and PT. Receives: Drug: Opioid-Free/Opioid-Avoidant |
| Opioid-Containing | Active comparator | Managed post-operatively with a traditional opioid containing pain regimen including:
Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound.
Post-operative morphine IV for breakthrough pain.
Oral narcotic (hydrocodone/acetaminophen).
Gabapentin PO 300 mg TID x 30 days.
Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours.
Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs.
Acetaminophen PO dosed per body weight and discharged home with PO tabs.
Diazepam PO dosed per body weight during stay and discharged home with PO tabs.
Non-medicinal therapy: Ice, Early mobilization and PT. Receives: Drug: Opioid-Containing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain rating on the 10-point numeric pain rating scale (NPRS)
Pain rating on the 10-point numeric pain rating scale (NPRS) 24 hours after surgery completion
Measured: 24 hours after surgery completion
Secondary outcomes (14)
Morphine milliequivalents (MME)
Morphine milliequivalents (MME) while inpatient
Measured: Perioperative/Periprocedural
Length of hospital stay
Length of hospital stay (in days/hours)
Measured: Perioperative/Periprocedural
opioid medication prescribed
Presence of opioid medication prescribed at discharge
Measured: Perioperative/Periprocedural
Clinic phone calls regarding uncontrolled pain
Clinic phone calls regarding uncontrolled pain
Measured: Through study completion, an average of 1 year
Delayed opioid prescriptions sent
Delayed opioid prescriptions sent
Measured: Through study completion, an average of 1 year
Opioid refills requested or sent
Number of opioid refills requested or sent
Measured: Through study completion, an average of 1 year
Unplanned emergency department or clinic visits for pain
Instances of unplanned emergency department or clinic visits for pain
Measured: Through study completion, an average of 1 year
Days missed from school
Number of days missed from school
Measured: Through study completion, an average of 1 year
symptomatic pseudoarthrosis
Incidence of symptomatic pseudoarthrosis, confirmed either with computed tomography or during subsequent surgery
Measured: Through study completion, an average of 1 year
Numeric Pain Rating Scale (NPRS) - Patient
Numeric Pain Rating Scale (NPRS) according to the patient.
Measured: Through study completion, an average of 1 year
Perceived Numeric Pain Rating Scale (NPRS) - Parent/Guardian
Perceived Numeric Pain Rating Scale (NPRS) according to Parent/Guardian (0-10 with 10 being the worst)
Measured: Through study completion, an average of 1 year
Patient Acceptable Symptom State (PASS) (patient)
Patient Acceptable Symptom State (PASS) completed by patient, a single yes or no question
Measured: Through study completion, an average of 1 year
Patient Acceptable Symptom State (PASS) (parent/guardian)
Patient Acceptable Symptom State (PASS) according to the parent/guardian, a single yes or no question
Measured: Through study completion, an average of 1 year
Opioid medication utilization
Opioid medication utilization (Yes/No) after discharge
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start14 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies 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
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Paloski, DO, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935331
- Sponsor's protocol ID
- 9209
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Opioid-Free Versus Traditional Opioid-Containing Postoperative Pain Management Pathways for Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06935331
- Acronym / sponsor ID
- 9209
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Adolescent Idiopathic Scoliosis (AIS), Opioid, Pain Management Pathway
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Apr 2025 (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 purpose of this study is to compare the efficacy of a multimodal opioid-free (OF) pain management protocol with a traditional opioid-containing (OC) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis.
Detailed description
Opioids are the most common controlled medication used medically and non-medically by adolescents in the United States. Opioid prescribing practices are inextricably linked with the ongoing public health crisis of opioid misuse in the peri-adolescent population. However, the immediate postoperative period following instrumented posterior spinal fusion (PSF) for idiopathic scoliosis represents a difficult challenge for patients and surgeons alike - particularly with regard to pain control. Opioid medications are commonly used to manage early postoperative pain in these patients, though are associated with potentially deleterious effects and remain at the center of a national health crisis. In particular for peri-adolescent patients, opioids are known to disrupt central nervous system maturation, which may lead to long-term behavioral dysfunction, including increased vulnerability to addiction in adulthood. On the other hand, it is well-recognized that inadequate pain control is associated with atelectasis, delayed mobilization, protracted hospitalization, and increased complication rates following posterior instrumented PSF for idiopathic scoliosis. Consequently, there is a rising, unmet need to develop postoperative recovery pathways for this population, aimed at efficient and safe pain management that minimizes or eliminates opioids while ensuring a positive postoperative experience for the patient.
Previous studies in adult and pediatric patients have compared traditional opioid-based pain regimens to opioid-sparing regimens in the perioperative period, but have been limited by high rates of crossover, retrospective designs, reliance on indwelling pain catheters, reliance on opioids for early postoperative analgesia, and/or lack of patient-reported outcomes. While there are growing efforts to investigate and adopt opioid-free (OF) protocols in adult orthopaedic patients, such protocols have yet to be thoroughly evaluated in the pediatric population. A prior study approved and completed (Protocol# PED032) by Dr. Michael Paloski and team demonstrated that a comprehensive, multimodal, OF pain management pathway following instrumented PSF for idiopathic scoliosis results in equivalent length of stay and fewer opioids prescribed at discharge compared with a traditional opioid-containing (OC) pathway. To our knowledge, this was the first study to show that completely OF postoperative pain management is possible in this population. Additional studies, including the study proposed here, are necessary to evaluate patient-reported outcomes in this population when OF pain management is utilized and to delineate patient-specific and procedure-specific details that may predict success with an OF regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-Free/Opioid-Avoidant | Experimental | Drug: Opioid-Free/Opioid-AvoidantManaged post-operatively with an opioid-free pain regimen which will include: Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound. Gabapentin PO 300 mg TID x 30 days. Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours. Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs. Acetaminophen PO dosed per body weight and discharged home with PO tabs. Diazepam PO dosed per body weight during stay and discharged home with PO tabs. Non-medicinal therapy: Ice, Aromatherapy, Music therapy, Pet therapy, Early mobilization and PT. |
| Opioid-Containing | Active comparator | Drug: Opioid-ContainingManaged post-operatively with a traditional opioid containing pain regimen including: Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound. Post-operative morphine IV for breakthrough pain. Oral narcotic (hydrocodone/acetaminophen). Gabapentin PO 300 mg TID x 30 days. Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours. Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs. Acetaminophen PO dosed per body weight and discharged home with PO tabs. Diazepam PO dosed per body weight during stay and discharged home with PO tabs. Non-medicinal therapy: Ice, Early mobilization and PT. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric patients (10-20 years of age at the time of surgery)
- Diagnosis of idiopathic scoliosis
- Undergoing primary instrumented PSF
Key exclusion criteria (3 listed)
- Age <10 years or >20 years at time of surgery
- Patients with non-idiopathic scoliosis etiology, ie neuromuscular or syndromic scoliosis
- Patients undergoing non-fusion spinal surgeries, ie growing rods or tethering
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 |
|---|---|---|
| Opioid-Free/Opioid-AvoidantManaged post-operatively with an opioid-free pain regimen which will include: Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound Gabapentin PO 300 mg TID x 30 days Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs Acetaminophen PO dosed per body weight and discharged home with PO tabs Diazepam PO dosed per body weight during stay and discharged home with PO tabs Non-medicinal therapy: Ice, Aromatherapy, Music therapy, Pet therapy, Early mobilization and PT | Drug | Opioid-Free/Opioid-Avoidant |
| Opioid-ContainingManaged post-operatively with a traditional opioid containing pain regimen including: Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound Post-operative morphine IV for breakthrough pain Oral narcotic (hydrocodone/acetaminophen) Gabapentin PO 300 mg TID x 30 days Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs Acetaminophen PO dosed per body weight and discharged home with PO tabs Diazepam PO dosed per body weight during stay and discharged home with PO tabs Non-medicinal therapy: Ice, Early mobilization and PT | Drug | Opioid-Containing |
Primary outcome
Pain rating on the 10-point numeric pain rating scale (NPRS)
Time frame: 24 hours after surgery completion
Pain rating on the 10-point numeric pain rating scale (NPRS) 24 hours after surgery completion
14 secondary outcomes
Morphine milliequivalents (MME)
Time frame: Perioperative/Periprocedural
Length of hospital stay
Time frame: Perioperative/Periprocedural
opioid medication prescribed
Time frame: Perioperative/Periprocedural
Clinic phone calls regarding uncontrolled pain
Time frame: Through study completion, an average of 1 year
Delayed opioid prescriptions sent
Time frame: Through study completion, an average of 1 year
Opioid refills requested or sent
Time frame: Through study completion, an average of 1 year
Unplanned emergency department or clinic visits for pain
Time frame: Through study completion, an average of 1 year
Days missed from school
Time frame: Through study completion, an average of 1 year
symptomatic pseudoarthrosis
Time frame: Through study completion, an average of 1 year
Numeric Pain Rating Scale (NPRS) - Patient
Time frame: Through study completion, an average of 1 year
Perceived Numeric Pain Rating Scale (NPRS) - Parent/Guardian
Time frame: Through study completion, an average of 1 year
Patient Acceptable Symptom State (PASS) (patient)
Time frame: Through study completion, an average of 1 year
Patient Acceptable Symptom State (PASS) (parent/guardian)
Time frame: Through study completion, an average of 1 year
Opioid medication utilization
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No. No plan
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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.
Michael Paloski, DO principal investigator
OrthoCarolina Research Institute, Inc.
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 Opioid-Free/Opioid-Avoidant and Opioid-Containing in people with Adolescent Idiopathic Scoliosis (AIS), run by OrthoCarolina Research Institute, Inc. 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain rating on the 10-point numeric pain rating scale (NPRS) (time frame: 24 hours after surgery completion). 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 6 Apr 2026.