Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:
• ≥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
Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Sara Olenich, MS
sara.olenich@childrens.harvard.edu
(617) 355-6000
Backup
Mikayla Flowers, MA
Mikayla.Flowers@childrens.harvard.edu
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 128
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Boston Children's Hospital