Rib Microtia and the Erector Spinae Plane (ESP) Block

Anesthesia Clinical Trial

Official title:

Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03729427
• Other study ID #: 45160
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: Ahtziri Fonseca
• Phone: 650-497-0927
• Email: aef22011[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia, Local
• Microtia
• Microtia, Congenital

Intervention

Procedure:
• Erector Spinae Plane Block
Erector Spinae Plane block for patents undergoing rib cartilage grafting surgeries

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate Intake in Morphine Equivalents in Both Control and Treatment Group		Duration of procedure and postoperative recovery (throughout study completion, typically 4-5 days)
Primary	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)
Primary	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)
Primary	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)