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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

No Placebo-Only Group

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

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I have been diagnosed with Adolescent Idiopathic Scoliosis.

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I am between 10 and 17 years old.

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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:

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I cannot fluently read or speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-, 6-, 12-, and 24-months postoperatively

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total amount of morphine equivalents per kilogram

Secondary study objectives

Numeric Rating Scale (NRS) pain scores

Pain, functional ability, and mental health scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met