Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-01-31 @ 4:03 PM
Study NCT ID:
NCT05069961
Status:
WITHDRAWN
Last Update Posted:
2023-10-31
First Post:
2021-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Non- Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural Analgesia in Multimodal Pain Management of Multiple Rib Fractures
Status:
WITHDRAWN
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was closed with IRB as PI wants to design the protocol extensively.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUETHE-Ribs
Brief Summary:
The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.
Detailed Description:
2.1 Primary Objective
* Compare efficacy of ESPB to TEA for MRF analgesia.
2.2 Secondary Objective
* Compare systemic opioid and non-opioid medication use in patients with ESPB and TEA.
2.3 Tertiary/Exploratory/Correlative Objectives
* Determine improvement in respiratory function in ESPB versus TEA before and after analgesia placement.
* Compare complications that occur in patients who receive ESPB versus TEA.
* Compare dermatome levels relative to catheter placement that achieve analgesia for TEA and ESPB.
* Compare differences in deep vein thrombosis (DVT) prophylaxis and incidence between ESPB and TEA.
* Differences in length of stay (LOS) for TEA versus ESPB.
* Differences in risk of delirium between TEA and ESPB.
* Differences in oxygen and ventilatory support between TEA and ESPB.
* Patient satisfaction of pain management.
* Compare efficacy of ESPB to TEA for MRF analgesia.
2.2 Secondary Objective
* Compare systemic opioid and non-opioid medication use in patients with ESPB and TEA.
2.3 Tertiary/Exploratory/Correlative Objectives
* Determine improvement in respiratory function in ESPB versus TEA before and after analgesia placement.
* Compare complications that occur in patients who receive ESPB versus TEA.
* Compare dermatome levels relative to catheter placement that achieve analgesia for TEA and ESPB.
* Compare differences in deep vein thrombosis (DVT) prophylaxis and incidence between ESPB and TEA.
* Differences in length of stay (LOS) for TEA versus ESPB.
* Differences in risk of delirium between TEA and ESPB.
* Differences in oxygen and ventilatory support between TEA and ESPB.
* Patient satisfaction of pain management.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: