Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04681547
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2020-12-15
Brief Title:
Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Ultrasound-guided Genicular Nerve Block An Analgesic Alternative to LIA for Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2021-05
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:
PGENECA
Brief Summary:
The hypothesis is to demonstrate the analgesic non-inferiority of the ultrasound-guided geniculate nerve block when compared to the local infiltration analgesia LIA It is expected to maintain the quality of analgesia with a selective blockade of the nerves responsible for the sensitive innervation of the knee reducing the total dose of local anesthetic and adrenaline very markedly
Detailed Description:
The main objective is to demonstrate that the ultrasound-guided geniculate nerve block provides not-inferior analgesia to LIA in patients undergoing primary total knee arthroplasty TKA in the first 24 hours postoperatively and during the first mobilization using the numerical evaluation of the pain NRS
The secondary objectives are to demonstrate that the consumption of opioids and the range of joint mobility are not inferior in those patients who receive geniculate nerve blocks compared to those who receive LIA
The secondary objectives are to demonstrate that the consumption of opioids and the range of joint mobility are not inferior in those patients who receive geniculate nerve blocks compared to those who receive LIA
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-005010-19 | EUDRACT_NUMBER | None | None |