Recruiting

Liposomal Bupivacaine

Sponsor:

Boston Children's Hospital

Code:

NCT06471348

Conditions

Post Operative Pain

Spinal Fusion

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Bupivacaine liposome injectable suspension

Bupivacaine Hydrochloride and Epinephrine Injection

Study Details

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

Study ID

NCT06471348

Start date

Aug 15, 2025

Status verified date

Oct, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥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

Exclusion Criteria:

  • 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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Local infiltration with liposomal bupivacaine

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.

active comparator: Local infiltration with 0.25% bupivacaine with epinephrine

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.

Interventions

Bupivacaine liposome injectable suspension

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 Injection

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).

Primary outcome measure

  • Total amount of morphine equivalents per kilogram [ Time Frame: 72 hours postoperatively ]

Central Contacts and Locations

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Craig Birch, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-10-22.