Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03664973
Status:
UNKNOWN
Last Update Posted:
2019-05-09
First Post:
2018-09-02
Brief Title:
Serratus Plane Block for Rib Fractures
Sponsor:
Arcispedale Santa Maria Nuova-IRCCS
Organization:
Arcispedale Santa Maria Nuova-IRCCS
Study Overview
Official Title:
Effect of the Serratus Plane Block on the Outcome in Patient With Multiple Rib Fractures A Prospective Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Patients with ipsilateral multiple rib fractures will be randomized to receive either a single-shot ultrasound-guided serratus plane block or a continuous serratus plane block within 24h from the chest trauma Primary outcome is the difference in forced respiratory volume FEV1 at 72h
Detailed Description:
Patients admitted in emergency department with a chest trauma and ipsilateral multiple rib fractures will be randomized as described above All patients will receive the serratus block with a ropivacaine 037 solution 20 ml Then they will randomized to receive either a peripheral catheter placed above the 5th rib on the middle axillary line or nothing In all patients postoperative analgesia also include Paracetamol 1g IV each 6h and a patient controlled analgesia PCA of morphine set out as follow bolus 1 mg loch out 15 min max 4 boluses each hour In all patients an arterial blood sample for gas analysis and a FEV1 will be achieved before the block after 1 hour and at 72h
Study Oversight
Has Oversight DMC:
None
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?:
None