Rib Microtia and the Erector Spinae Plane (ESP) Block

April 30, 2025 updated by: Chi-Ho Ban Tsui, Stanford University

Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery

The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. This study is being performed to assess the effectiveness of this technique in reducing post-operative pain scores and opiate requirements in pediatric and adult patients undergoing rib cartilage grafting surgeries.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Lucile Packard Children's Hospital Stanford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ages 2-17
  • Able to consent (if greater than 7 years) and have parental consent
  • Pediatric patients undergoing rib cartilage resection surgeries

Exclusion Criteria:

  • Participants who do not consent or have parental consent
  • Patients who are clinically unstable or requires urgent/emergent intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
ESP Block
Procedure: Erector Spinae Plane Block
Erector Spinae Plane block for patents undergoing rib cartilage grafting surgeries
No Intervention: Control Arm
Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opiate Intake in Morphine Equivalents in Both Control and Treatment Group
Time Frame: Duration of procedure and postoperative recovery (throughout study completion, typically 4-5 days)
Duration of procedure and postoperative recovery (throughout study completion, typically 4-5 days)
Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain)
Time Frame: Duration of Study (Typically 4-5 days)
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Duration of Study (Typically 4-5 days)
Evaluating Pain Scores Using Wong-Baker FACES Pain Rating Scale
Time Frame: Duration of Study (Typically 4-5 days)
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Duration of Study (Typically 4-5 days)
Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale
Time Frame: Duration of Study (Typically 4-5 days)
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Duration of Study (Typically 4-5 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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