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Erector Spinae vs Paravertebral Block for Postoperative Pain

Phase 3
Recruiting
Led By ROLAND BRUSSEAU, 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
ASA I - III status, undergoing unilateral thoracotomy for either esophageal atresia related intrathoracic procedures or other non-cardiac general surgical intrathoracic procedures.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24, 48 and 72 hours
Awards & highlights

Study Summary

This trial is comparing two types of pain relief after surgery to see which is better.

Who is the study for?
This trial is for children and adolescents with ASA I - III status who are undergoing unilateral thoracotomy for specific intrathoracic procedures. It's not suitable for those with extensive pleural disruption, severe neurodevelopmental delays, chronic pain syndromes, recent opioid treatment, or without parental consent.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of two types of pain relief blocks after surgery: continuous erector spinae block (ESB) and continuous paravertebral block (PVB), both using Ropivacaine. The goal is to see if ESB provides similar pain control to PVB at 24 hours post-surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, low blood pressure, nausea, itching or rash due to Ropivacaine. Rarely there could be more serious nerve damage or reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having surgery on one side of my chest for esophageal or other non-heart issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24, 48 and 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24, 48 and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Number of Adverse events
Pain scores
Rescue analgesic consumption
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: continuous erector spinae blockExperimental Treatment2 Interventions
An erector spinae block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
Group II: continuous paravertebral blockActive Control2 Interventions
A paravertebral block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
2017
Completed Phase 4
~1960

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,630 Total Patients Enrolled
3 Trials studying Postoperative Pain
145 Patients Enrolled for Postoperative Pain
ROLAND BRUSSEAU, MDPrincipal InvestigatorBoston Children's Hospital
3 Previous Clinical Trials
211 Total Patients Enrolled
1 Trials studying Postoperative Pain
45 Patients Enrolled for Postoperative Pain

Media Library

Continuous Erector Spinae Block Clinical Trial Eligibility Overview. Trial Name: NCT03768440 — Phase 3
Postoperative Pain Research Study Groups: continuous erector spinae block, continuous paravertebral block
Postoperative Pain Clinical Trial 2023: Continuous Erector Spinae Block Highlights & Side Effects. Trial Name: NCT03768440 — Phase 3
Continuous Erector Spinae Block 2023 Treatment Timeline for Medical Study. Trial Name: NCT03768440 — Phase 3

Frequently Asked Questions

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

Who meets the screening requirements for this clinical trial?

"This trial is designed for children aged 6 months to 6 years who are postoperative and experiencing pain. 100 young patients will be accepted in total."

Answered by AI

Are there other instances in which continuous ESB has been studied?

"There are 72 ongoing research projects investigating continuous erector spinae block (ESB). Out of these, 16 are in Phase 3. Most trials for continuous erector spinae block (ESB) originate from Karachi, Sindh; however, there are a total of 92 locations conducting studies related to this topic."

Answered by AI

ESB is often recommended for which type of issues?

"ESB, or continuous erector spinae block, is a commonly used medical intervention for procedures like surgical anesthesia and labor. Additionally, this treatment can also be effective in managing postoperative pain."

Answered by AI

Are patients still being recruited for this experimental treatment?

"That is accurate. The information available on clinicaltrials.gov indicates that this study began recruiting on 4/16/2019 and is still looking for 100 individuals across 1 site."

Answered by AI

Is ESB an FDA-sanctioned form of treatment?

"There is available clinical evidence supporting the safety of continuous erector spinae block (ESB), which our team at Power has rated a 3 on a scale from 1 to 3."

Answered by AI

How many test subjects are involved in this experiment?

"That is correct. The website clinicaltrials.gov has the most recent information on this topic, which says that the study was posted on 4/16/2019 and updated as recently as 3/8/2022. They are looking for 100 patients from 1 site."

Answered by AI

Does the age limit for this experiment extend past 85 years old?

"The current enrolment for this trial are young patients that have not reached 6 years old, but are older than 6 months."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Continuous Erector Spinae Block Versus Continuous Paravertebral Block
Roland Brusseau 2019. "Continuous Erector Spinae Block Versus Continuous Paravertebral Block". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03768440.
~10 spots leftby Dec 2024
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