Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03920930
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2019-04-16
Brief Title:
Optimization of a Fast-track Concept for Knee Joint Replacement
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Optimization of a Fast-track Concept for Knee Replacement A Single-blind Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-02
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:
KneeOptOut2
Brief Summary:
In an estimated 150000 patients a knee joint replacement is performed in Germany every year The perioperative care of the patients aims at an optimal surgical technique which leads to a high functionality in the joint and above all at an adequate pain treatment Patients experience pain especially intraoperatively and in the first days after the operation The intensity of pain is a decisive factor that can hinder the patients mobilization In the KneeOptOut study ethics application number EA400917 which has already been successfully carried out and approved by this ethics committee it was shown that the use of local infiltration anaesthesia LIA for pain therapy after primary knee endoprosthetics is comparable to catheter-supported regional anaesthesia manuscript under review at the European Journal of Anaesthesiology During surgery the morphine requirement of patients in the LIA group was significantly higher than that of patients who underwent catheterization Postoperatively however both subjective pain by VAS and opiate consumption were comparable
In order to optimize the intraoperative opiate needconsumption an early-intraoperative procedure for local infiltration anesthesia will now be compared with the previous late-intraoperative procedure Both procedures correspond to SOP for the treatment of primary knee endoprostheses and are currently used depending on the surgeons requirements
In order to optimize the intraoperative opiate needconsumption an early-intraoperative procedure for local infiltration anesthesia will now be compared with the previous late-intraoperative procedure Both procedures correspond to SOP for the treatment of primary knee endoprostheses and are currently used depending on the surgeons requirements
Detailed Description:
None
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