← Back to Search

Local Anesthetic

Liposomal Bupivacaine vs. Bupivacaine with Epinephrine for Postoperative Pain

N/A
Waitlist Available
Led By Craig Birch, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Adolescent Idiopathic Scoliosis
≥10 years old and ≤17 years old at assessment
Must not have
Diagnosis of neuromuscular, syndromic, or congenital scoliosis
Cannot fluently read or speak English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 6-, 12-, and 24-months postoperatively
Awards & highlights

Summary

This trial compared two different types of pain relief injections given during spinal fusion surgery for adolescent idiopathic scoliosis. The study aimed to see which injection was better at reducing the amount of painkillers

Who is the study for?
This trial is for young patients aged 10 to 17 who are undergoing posterior spinal fusion surgery for Adolescent Idiopathic Scoliosis (AIS). It's designed to see if a new pain control method works better after surgery. Patients with certain health conditions or on medications that could interfere with the study may not be eligible.
What is being tested?
The study compares two types of local anesthetic injections: liposomal bupivacaine and regular bupivacaine with epinephrine, in terms of reducing the need for opioids after spine surgery. Participants will be randomly placed into one of these two treatment groups.
What are the potential side effects?
Possible side effects include reactions at the injection site, nausea, vomiting, headache, fever, back pain, constipation or dizziness. Both drugs have been used before but comparing their effectiveness and side effects post-surgery is part of this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Adolescent Idiopathic Scoliosis.
Select...
I am between 10 and 17 years old.
Select...
I am scheduled for surgery to correct a worsening curve in my spine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot fluently read or speak English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-, 6-, 12-, and 24-months postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-, 6-, 12-, and 24-months postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total amount of morphine equivalents per kilogram
Secondary outcome measures
Numeric Rating Scale (NRS) pain scores
Pain, functional ability, and mental health scores

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Local infiltration with liposomal bupivacaineExperimental Treatment1 Intervention
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.
Group II: Local infiltration with 0.25% bupivacaine with epinephrineActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine liposome injectable suspension
2018
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
773 Previous Clinical Trials
5,580,823 Total Patients Enrolled
3 Trials studying Postoperative Pain
145 Patients Enrolled for Postoperative Pain
Craig Birch, MDPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Postoperative Pain
100 Patients Enrolled for Postoperative Pain
~85 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top