Rib Microtia and the Erector Spinae Plane (ESP) Block

NCT03729427 | Withdrawn

• 1 other identifier: 45160
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Microtia, Congenital; Microtia; Anesthesia, Local; Anesthesia

Keywords

Erector Spinae Plane; Erector Spiane Plane Block; Rib Cartilage

Outcome Measures

Primary Outcomes (4)

• Opiate Intake in Morphine Equivalents in Both Control and Treatment Group

  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)

  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

  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

  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)

Study Arms (2)

Treatment Arm

EXPERIMENTAL

ESP Block

Procedure: Erector Spinae Plane Block

Control Arm

NO INTERVENTION

Standard of Care

Interventions

Erector Spinae Plane Block PROCEDURE

Erector Spinae Plane block for patents undergoing rib cartilage grafting surgeries

Treatment Arm

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Related Publications (3)

• 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.

  PMID: 28919152 BACKGROUND

• 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.

  PMID: 29301653 BACKGROUND

• 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.

  PMID: 28203765 BACKGROUND

MeSH Terms

Conditions

Congenital Microtia

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Med Ctr Line

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 2, 2018
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)