Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine

NCT06471348 | Recruiting

• 1 other identifier: IRB-P00048597
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Total amount of morphine equivalents per kilogram

  Total amount of morphine equivalents per kilogram during the first 72 hours postoperatively.

  72 hours postoperatively

Secondary Outcomes (2)

• Numeric Rating Scale (NRS) pain scores

  72 hours postoperatively

• Pain, functional ability, and mental health scores

  1-, 6-, 12-, and 24-months postoperatively

Study Arms (2)

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.

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.

Drug: Bupivacaine Hydrochloride and Epinephrine Injection

Interventions

Bupivacaine liposome injectable suspension DRUG

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.

Also known as: EXPAREL

Local infiltration with liposomal bupivacaine

Bupivacaine Hydrochloride and Epinephrine Injection DRUG

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).

Also known as: Sensorcaine-MPF with Epinephrine 1:200,000

Local infiltration with 0.25% bupivacaine with epinephrine

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Craig Birch, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Olenich, MS

CONTACT

(617) 355-6000; sara.olenich@childrens.harvard.edu

Mikayla Flowers, MA

CONTACT

Mikayla.Flowers@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Orthopedic Surgery, Harvard Medical School

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 24, 2024
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)