← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-, 6-, and 12-months post-operatively

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 10 and 17 years old.

Select...

I am scheduled for surgery to correct a worsening curve in my spine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-, 6-, and 12-months post-operatively

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual Analog Scale (VAS) pain score

Secondary outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,630 Total Patients Enrolled

Craig Birch, MDPrincipal InvestigatorBoston Children's Hospital

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens eligible for enrolment in this clinical trial?

"Recruitment into the trial is opened to minors who are between 10 and 17 years old."

Answered by AI

What is the upper limit for participants in this exploration?

"Affirmative. Per the information found on clinicaltrials.gov, this medical research project is in need of volunteers and was originally posted to the website on June 2nd 2022 before being updated most recently on August 23rd 2022. The trial requires 100 participants from a single site."

Answered by AI

To which demographic can this trial offer its benefits?

"Prospective participants for this clinical trial ought to have the relevant medical condition and be aged between 10 years and 17 years old. About 100 persons will be included in this research."

Answered by AI

Is the opportunity for participation in this research experiment available to prospective participants?

"Affirmative. According to the data on clinicaltrials.gov, this trial is currently enrolling volunteers for participation. It was first posted on June 2nd 2022 and last updated August 23rd 2022; 100 participants are needed across a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery

Craig Birch 2022. "Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04730531.

All > Exparel