Post Operative PainNCT06471348
Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine
A study testing Bupivacaine liposome injectable suspension and Bupivacaine Hydrochloride and Epinephrine Injection in people with Post Operative Pain and Spinal Fusion, run by Boston Children's Hospital at 1 site in United States.
Trial summary
A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Post Operative Pain, Spinal Fusion
- What is being tested?
- Bupivacaine liposome injectable suspension and Bupivacaine Hydrochloride and Epinephrine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 31 Aug 2028
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥10 years old and ≤17 years old at assessment
- Diagnosis of Adolescent Idiopathic Scoliosis
- Planned surgical treatment of progressive spinal deformity with posterior spinal fusion
Who cannot join
- Diagnosis of neuromuscular, syndromic, or congenital scoliosis
- History of known allergy to local anesthesia
- Chronic pre-operative opioid consumptions
- Any other analgesic treatment for chronic pain before surgery
- Psychiatric or neurological disorders
- Cannot fluently read or speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mikayla Flowers, MA contact
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Sara Olenich, MS, (617) 355-6000, sara.olenich@childrens.harvard.edu
Craig Birch, MD
About this study
Official title: Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine
A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.
- Conditions
- Post Operative Pain, Spinal Fusion
- Being tested
- Bupivacaine liposome injectable suspension, Bupivacaine Hydrochloride and Epinephrine Injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine liposome injectable suspensionDrug
Also called EXPAREL
EXPAREL is a milky white too off-white aqueous suspension available as single-dose vials. Each mL contains 13.3 mg of bupivacaine, which is contained in multivesicular liposomes.
Bupivacaine Hydrochloride and Epinephrine InjectionDrug
Also called Sensorcaine-MPF with Epinephrine 1:200,000
Sensorcaine-MPF with Epinephrine 1:200,000 is a clear, colorless to slightly yellow solution available as single-dose vials. Each mL contains bupivacaine hydrochloride, 0.005 mg epinephrine, and 0.5 mg sodium metabisulfite (antioxidant), and 0.2 mg anhydrous citric acid (stabilizer).
| Study group | Role | What they receive |
|---|---|---|
| Local infiltration with liposomal bupivacaine | Experimental | Patients randomized into the liposomal bupivacaine group will receive anesthesia and undergo standard posterior spinal fusion surgery. The local infiltration would occur in a single stage, after instrumentation and correction maneuver is performed, just prior to closure of the deep fascial layer. The dose would be injected via multiple small volume injections into the paraspinal musculature, spaced approximately 1 cm apart. Receives: Drug: Bupivacaine liposome injectable suspension |
| Local infiltration with 0.25% bupivacaine with epinephrine | Active comparator | Patients randomized into the 0.25% bupivacaine with epinephrine group will receive anesthesia and undergo standard posterior spinal fusion surgery under the same condition as the intervention group with one exception: the local infiltration will be made up of equal volume of 0.25% bupivacaine with epinephrine. The equal volume of 0.25% bupivacaine with epinephrine will be used in the exact same administration technique as the liposomal bupivacaine group, involving multiple small-volume injections to the paraspinal musculature spaced approximately 1 centimeter apart. Receives: Drug: Bupivacaine Hydrochloride and Epinephrine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of morphine equivalents per kilogram
Total amount of morphine equivalents per kilogram during the first 72 hours postoperatively.
Measured: 72 hours postoperatively
Secondary outcomes (2)
Numeric Rating Scale (NRS) pain scores
The average Numeric Rating Scale pain score (on a scale of 0-10) during the first 72 hours postoperatively will be computed from at most six values typically obtained every four to six hours following surgery. The higher the score, the higher the experienced pain of the individual.
Measured: 72 hours postoperatively
Pain, functional ability, and mental health scores
SRS-22r scores at 1-, 6-, 12-, and 24-months post-operatively. The Scoliosis Patient Questionnaire Version 22r (SRS-22r) is a patient-reported outcome instrument with 22 questions that evaluates the impact of scoliosis and surgery on patient quality of life. Scores from the SRS-22r are compiled into five domain scores: function, pain, self-image, mental health, and satisfaction with management of scoliosis. Each domain score is reported on a scale form 1-5. The lower the score, the worse the outcome.
Measured: 1-, 6-, 12-, and 24-months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start15 Aug 2025
- Primary completion15 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Birch, Boston Children's Hospital
- Investigators
- Craig Birch, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471348
- Sponsor's protocol ID
- IRB-P00048597
- Status last verified
- Oct 2025
- First submitted
- 21 May 2024
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine
- ClinicalTrials.gov ID
- NCT06471348
- Acronym / sponsor ID
- IRB-P00048597
- Conditions
- Post Operative Pain, Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 24 Jun 2024 (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.
A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local infiltration with liposomal bupivacaine | Experimental | Drug: Bupivacaine liposome injectable suspensionPatients randomized into the liposomal bupivacaine group will receive anesthesia and undergo standard posterior spinal fusion surgery. The local infiltration would occur in a single stage, after instrumentation and correction maneuver is performed, just prior to closure of the deep fascial layer. The dose would be injected via multiple small volume injections into the paraspinal musculature, spaced approximately 1 cm apart. |
| Local infiltration with 0.25% bupivacaine with epinephrine | Active comparator | Drug: Bupivacaine Hydrochloride and Epinephrine InjectionPatients randomized into the 0.25% bupivacaine with epinephrine group will receive anesthesia and undergo standard posterior spinal fusion surgery under the same condition as the intervention group with one exception: the local infiltration will be made up of equal volume of 0.25% bupivacaine with epinephrine. The equal volume of 0.25% bupivacaine with epinephrine will be used in the exact same administration technique as the liposomal bupivacaine group, involving multiple small-volume injections to the paraspinal musculature spaced approximately 1 centimeter apart. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ≥10 years old and ≤17 years old at assessment
- Diagnosis of Adolescent Idiopathic Scoliosis
- Planned surgical treatment of progressive spinal deformity with posterior spinal fusion
Key exclusion criteria (6 listed)
- Diagnosis of neuromuscular, syndromic, or congenital scoliosis
- History of known allergy to local anesthesia
- Chronic pre-operative opioid consumptions
- Any other analgesic treatment for chronic pain before surgery
- Psychiatric or neurological disorders
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 |
|---|---|---|
| Bupivacaine liposome injectable suspensionAlso: EXPARELEXPAREL is a milky white too off-white aqueous suspension available as single-dose vials. Each mL contains 13.3 mg of bupivacaine, which is contained in multivesicular liposomes. | Drug | Local infiltration with liposomal bupivacaine |
| Bupivacaine Hydrochloride and Epinephrine InjectionAlso: Sensorcaine-MPF with Epinephrine 1:200,000Sensorcaine-MPF with Epinephrine 1:200,000 is a clear, colorless to slightly yellow solution available as single-dose vials. Each mL contains bupivacaine hydrochloride, 0.005 mg epinephrine, and 0.5 mg sodium metabisulfite (antioxidant), and 0.2 mg anhydrous citric acid (stabilizer). | Drug | Local infiltration with 0.25% bupivacaine with epinephrine |
Primary outcome
Total amount of morphine equivalents per kilogram
Time frame: 72 hours postoperatively
Total amount of morphine equivalents per kilogram during the first 72 hours postoperatively.
2 secondary outcomes
Numeric Rating Scale (NRS) pain scores
Time frame: 72 hours postoperatively
Pain, functional ability, and mental health scores
Time frame: 1-, 6-, 12-, and 24-months postoperatively
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 22 Oct 2025.
- 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.
Mikayla Flowers, MA contact
Craig Birch, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine liposome injectable suspension and Bupivacaine Hydrochloride and Epinephrine Injection in people with Post Operative Pain and Spinal Fusion, run by Boston Children's Hospital 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 6 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: looking for participants now, as of the sponsor's last update on 22 Oct 2025. 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.
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?
Contact Sara Olenich, MS ((617) 355-6000, sara.olenich@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of morphine equivalents per kilogram (time frame: 72 hours postoperatively). 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 22 Oct 2025.