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

Recruitment Status

RECRUITING

Eligibility Criteria

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

Phase

NA

Gender

ALL

Min Age

10 Years

Max Age

17 Years

Download Date

2025-10-22

Principal Investigator

Primary Investigator

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Primary Contact Information

Contact Info
Sydney Lee, BA
Sydney.Lee@childrens.harvard.edu

Mikayla Flowers, MA
Mikayla.Flowers@childrens.harvard.edu

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Intervention

Intervention Type

DRUG

DRUG

Intervention Name

Bupivacaine liposome injectable suspension

Bupivacaine Hydrochloride and Epinephrine Injection

Contact

For more information and to contact the study team:

Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine NCT06471348 Sydney Lee, BA Sydney.Lee@childrens.harvard.edu Mikayla Flowers, MA Mikayla.Flowers@childrens.harvard.edu