Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756791
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2021-02-11
Brief Title:
Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
Status:
RECRUITING
Status Verified Date:
2023-05
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:
SAPLIA
Brief Summary:
To evaluate whether a serratus anterior plane block SAPB is more effective than a local infiltration anesthesia LIA with an equal dose and same anesthetic performed by the surgeon as an adjuvant to treat postoperative pain after unilateral mastectomy
Detailed Description:
To evaluate whether a serratus anterior plane block SAPB is more effective than a local infiltration anesthesia LIA with an equal dose and same anesthetic performed by the surgeon as an adjuvant to treat postoperative pain after unilateral mastectomy
Primary endpoint the use of opioids in the postoperative period Secondary endpoint Numerical Pain Rating Scale NPRS score recorded at the 2nd 8th 16th 24th hour after surgery 0 means no pain and 10 is the worst pain imaginable In addition at the same time we will look to the degree of arm mobilization where there will be 3 possible groups 1 restricted 2 fair mobilization and 3 free mobilization
There are 2 treatment arms 1st arm is the standard therapy namely the local infiltration anesthesia 2nd arm is the experimental arm namely the SAPB Patients are randomised into each arm after screening
Primary endpoint the use of opioids in the postoperative period Secondary endpoint Numerical Pain Rating Scale NPRS score recorded at the 2nd 8th 16th 24th hour after surgery 0 means no pain and 10 is the worst pain imaginable In addition at the same time we will look to the degree of arm mobilization where there will be 3 possible groups 1 restricted 2 fair mobilization and 3 free mobilization
There are 2 treatment arms 1st arm is the standard therapy namely the local infiltration anesthesia 2nd arm is the experimental arm namely the SAPB Patients are randomised into each arm after screening
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?:
False
Is an FDA AA801 Violation?:
None