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Local Anesthetic Infiltration for Postoperative Pain After Spinal Fusion

N/A
Recruiting
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
≥10 years old and ≤17 years old at assessment
Planned surgical treatment of progressive spinal deformity with posterior spinal fusion
Must not have
Psychiatric or neurological disorders
Cannot fluently read or speak English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 6-, and 12-months post-operatively

Summary

This trial will assess the efficacy of local wound infiltration with anesthetic agents in reducing postoperative pain and postoperative opioid use in adolescent idiopathic scoliosis patients.

Who is the study for?
This trial is for young people aged 10-17 with Adolescent Idiopathic Scoliosis (AIS) who are planning to undergo spinal fusion surgery. It's not for those with other types of scoliosis, allergies to local anesthesia, chronic opioid use, other pain treatments before surgery, or psychiatric/neurological disorders.
What is being tested?
The study tests if injecting a local anesthetic (0.25% bupivacaine with epinephrine) near the wound can reduce post-surgery pain and opioid use in AIS patients after spinal fusion. Participants will be randomly assigned to receive either the anesthetic or a saline placebo.
What are the potential side effects?
Possible side effects include reactions at the injection site like swelling or redness, potential allergic reactions to bupivacaine or epinephrine, and less commonly symptoms such as dizziness or heart palpitations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 have a psychiatric or neurological disorder.
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I cannot fluently read or speak English.
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I have been diagnosed with a specific type of scoliosis related to muscle or genetic conditions.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Visual Analog Scale (VAS) pain score
Secondary study objectives
Average use of morphine equivalents
Scoliosis Patient Questionnaire - Version 30 (SRS-30)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
Local infiltration with 0.25% bupivacaine and epinephrine
Group II: Control ArmPlacebo Group1 Intervention
Placebo of equal volume injectable saline

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
785 Previous Clinical Trials
5,581,631 Total Patients Enrolled
Craig Birch, MDPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
128 Total Patients Enrolled

Media Library

Local infiltration with 0.25% bupivacaine and epinephrine Clinical Trial Eligibility Overview. Trial Name: NCT04730531 — N/A
Spinal Fusion Research Study Groups: Treatment Arm, Control Arm
Spinal Fusion Clinical Trial 2023: Local infiltration with 0.25% bupivacaine and epinephrine Highlights & Side Effects. Trial Name: NCT04730531 — N/A
Local infiltration with 0.25% bupivacaine and epinephrine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04730531 — N/A
~29 spots leftby Nov 2025
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