Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT03592056
Status:
TERMINATED
Last Update Posted:
2020-01-23
First Post:
2018-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions
Sponsor:
Clinica las Condes, Chile
Organization:
Study Overview
Official Title:
Incidence of Hemidiaphragmatic Paralysis Using 0.04% Levobupivacaine for Continuous Interscalene Brachial Plexus Blocks in Arthroscopic Shoulder Surgeries
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
interim analysis proved that protocol intervention had no preventive effect
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Interscalene brachial plexus block (ISB) constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. Continuous ISBs have not avoided this complication with the reported and regularly used local anesthetic dilutions (i.e. 0.125% bupivacaine, 0.25% ropivacaine, etc). This observational study will register the incidence of HDP in continuous interscalene block (CISB) using a very diluted solution of levobupivacaine (0.04%) in patients undergoing arthroscopic shoulder surgery.
The main objective of this study is to determine the frequency of HDP the first postoperative day before patient discharge(POD).
The main objective of this study is to determine the frequency of HDP the first postoperative day before patient discharge(POD).
Detailed Description:
None
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?: