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Rib Microtia and the Erector Spinae Plane (ESP) Block

Primary Purpose

Microtia, Congenital, Microtia, Anesthesia, Local

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microtia, Congenital focused on measuring Erector Spinae Plane, Erector Spiane Plane Block, Rib Cartilage

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lucile Packard Children's Hospital Stanford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Arm

Control Arm

Arm Description

ESP Block

Standard of Care

Outcomes

Primary Outcome Measures

Opiate Intake in Morphine Equivalents in Both Control and Treatment Group
Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain)
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Evaluating Pain Scores Using Wong-Baker FACES Pain Rating Scale
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.

Secondary Outcome Measures

Full Information

First Posted
October 29, 2018
Last Updated
April 17, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03729427
Brief Title
Rib Microtia and the Erector Spinae Plane (ESP) Block
Official Title
Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microtia, Congenital, Microtia, Anesthesia, Local, Anesthesia
Keywords
Erector Spinae Plane, Erector Spiane Plane Block, Rib Cartilage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
ESP Block
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Standard of Care
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
Erector Spinae Plane block for patents undergoing rib cartilage grafting surgeries
Primary Outcome Measure Information:
Title
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)
Title
Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain)
Description
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Time Frame
Duration of Study (Typically 4-5 days)
Title
Evaluating Pain Scores Using Wong-Baker FACES Pain Rating Scale
Description
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Time Frame
Duration of Study (Typically 4-5 days)
Title
Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale
Description
Scale will be used to asses pain initially prior to the procedure and postoperatively approximately every 6 hours.
Time Frame
Duration of Study (Typically 4-5 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahtziri Fonseca
Phone
650-497-0927
Email
aef22011@stanford.edu
Facility Information:
Facility Name
Lucile Packard Children's Hospital Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole Lin, MD
First Name & Middle Initial & Last Name & Degree
Chi-Ho Ban Tsui, MD
First Name & Middle Initial & Last Name & Degree
Carole Lin, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28919152
Citation
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
Results Reference
background
PubMed Identifier
29301653
Citation
Luftig J, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. Successful emergency pain control for posterior rib fractures with ultrasound-guided erector spinae plane block. Am J Emerg Med. 2018 Aug;36(8):1391-1396. doi: 10.1016/j.ajem.2017.12.060. Epub 2017 Dec 28.
Results Reference
background
PubMed Identifier
28203765
Citation
Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.
Results Reference
background

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Rib Microtia and the Erector Spinae Plane (ESP) Block

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