Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-30 @ 1:35 PM
Study NCT ID:
NCT05063695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pectus ESC Outcomes and Comparative Effectiveness Study
Sponsor:
Children's Hospital Medical Center, Cincinnati
Organization:
Study Overview
Official Title:
Pragmatic Study Comparing Outcomes of Multimodal Epidural and Erector Spinae Catheter Pain Protocols After Pectus Surgery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PectusESC
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: