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
NOT_YET_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
Intervention
Intervention Type
Intervention Name
DRUG
Bupivacaine liposome injectable suspension
DRUG
Bupivacaine Hydrochloride and Epinephrine Injection
Phase
NA
Gender
ALL
Min Age
10 Years
Max Age
17 Years
Download Date
2024-06-24
Principal Investigator
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
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.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: