Rib Microtia and the Erector Spinae Plane (ESP) Block

Not Applicable

Withdrawn

• Conditions: Microtia; Anesthesia, Local; Microtia, Congenital; Anesthesia

• Registration Number: NCT03729427
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Study Start: 2025-11
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluating Pain Scores Using Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale	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.
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 Wong-Baker FACES Pain Rating Scale	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.
Evaluating Pain Scores Using 0-10 Numeric Pain Scale (0=No Pain, 10=Worst Pain)	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.

Trial Locations

Locations (1)

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States