Pectus ESC Outcomes and Comparative Effectiveness Study

Active, not recruiting

• Conditions: Pain, Postoperative; Pectus Excavatum
• Interventions: Other: Multimodal Erector spinae catheter protocol

• Registration Number: NCT05063695
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Investigators hypothesize that Erector spinae catheter pain management protocol would allow patients to have earlier and more effective rehabilitation with decreased length of hospital stay. The aims are to compare LOS between the two groups (epidural and ES groups). Secondary aims are to compare recovery outcomes (mobilization time), time required to do the blocks, pain scores and opioid use during hospitalization and on follow up after discharge until Pain clinic visit, side effects, family satisfaction and readmissions among the two groups. In addition, in-hospital and post-discharge outcomes in subjects who received ESP protocol will be studied.

Detailed Description

Retrospective study - Electronic medical records of consecutive patients who underwent pectus surgery between January and December of 2019 (epidural protocol) and those who underwent same procedure between June 2020 to May 2021, will be evaluated. Covariates and outcomes described in sections below will be recorded from EMR. The data included records from flowsheets, pain team notes based on follow up questionnaires administered by phone after discharge until after ESP catheters were removed, as well as pain clinic notes.

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Age>8 years
• Diagnosis of pectus excavatum who underwent Nuss procedure
• Pain regimen included either epidural catheter or ES catheters

Exclusion Criteria

• Developmental delay
• prior pectus repair
• concomitant procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ESP	Multimodal Erector spinae catheter protocol	Patients who underwent Nuss procedure using ESP catheter protocol (June 2020 to April 2021)

Primary Outcome Measures

Name	Time	Method
Length of stay	Upto 10 days after surgery	Date of surgery to hospital discharge
Mobilization	After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)	Meeting PT goals

Secondary Outcome Measures

Name	Time	Method
Pain measures	After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)	Pain scores postoperative and opioid/benzodiazepine use
Side effects	After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)	ED visit, readmission, numbness, infection, LA toxicity etc.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States