Rib Microtia and the Erector Spinae Plane (ESP) Block

Overview

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.

Full Title of Study: “Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: December 2024

Interventions

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

Arms, Groups and Cohorts

• Experimental: Treatment Arm
  • ESP Block
• No Intervention: Control Arm
  • Standard of Care

Clinical Trial Outcome Measures

Primary Measures

• 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)
• 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.
• 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.
• 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Stanford University
• Provider of Information About this Clinical Study
  • Principal Investigator: Chi-Ho Ban Tsui, Professor-Med Ctr Line – Stanford University
• Overall Contact(s)
  • Ahtziri Fonseca, 650-497-0927, aef22011@stanford.edu

References

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.

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.

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.