Viewing Study NCT06038851



Ignite Creation Date: 2024-05-06 @ 7:30 PM
Last Modification Date: 2024-10-26 @ 3:08 PM
Study NCT ID: NCT06038851
Status: RECRUITING
Last Update Posted: 2023-10-17
First Post: 2023-08-29

Brief Title: Evaluation of the Analgesic Benefit of Adding the Blocks of the Intermediate and Medial Femoral Cutaneous Nerves in Addition to the Femoral Triangle Block for Postoperative Analgesia After a Knee Replacement Surgery
Sponsor: Centre hospitalier de lUniversité de Montréal CHUM
Organization: Centre hospitalier de lUniversité de Montréal CHUM

Study Overview

Official Title: Evaluation of the Analgesic Benefit of Adding the Blocks of the Intermediate and Medial Femoral Cutaneous Nerves in Addition to the Femoral Triangle Block for Postoperative Analgesia After a Knee Replacement Surgery A Randomized Controlled Clinical Trial
Status: RECRUITING
Status Verified Date: 2024-07
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: None
Brief Summary: Total knee replacement surgery can be associated with a significant postoperative pain burden and an inability to mobilize adequately which can lead to the failure of the ambulatory course

Indeed early mobilization is beneficial in this context in order to prevent complications related to immobility

The optimization of postoperative analgesia is therefore a key issue for the success of this intervention in an outpatient setting or during a short-term hospitalization since an adequate pain relief facilitate the earlier mobilization of the operated joint Modern postoperative analgesia protocols recommend a multimodal approach including the use of acetaminophen anti-inflammatories opioids and others as well as the use of nerve blocks

Some nerve blocks used for total knee replacement surgery such as the femoral nerve block do not preserve the motor skills of the operated limb which may alter the clinical trajectory due to delayed mobilization due to weakening of the quadriceps one of the extensor muscles of the knee Currently one of the blocks used to spare the motor functions is the block of the femoral triangle

Unfortunately this block of the femoral triangle does not fully cover the skin component of the surgical incision used for a total knee arthroplasty A solution to obtain a better quality of pain relief at the level of the cutaneous incision would be to add a block of the para-sartorial compartment which makes it possible to cover the nerve territories not covered by the femoral triangle block

The hypothesis of this study is that the addition of the para-sartorial compartments PACS block which aims to block the intermediate cutaneous femoral nerve will improve the postoperative analgesia after total knee replacement surgery compared to the classical isolated approach of the femoral triangle block FTB
Detailed Description: Despite many advances the postoperative analgesia offered by the present techniques remains imperfect the femoral triangle block does not make it possible to completely cover the cutaneous component of the classic midline incision used for a total knee arthroplasty This incision would fall more under the anterior cutaneous femoral nerves more specifically the intermediate and medial cutaneous femoral nerves A recently described approach offers the prospect of better covering this skin incision by specifically blocking these nerves using the same needle path as for the femoral triangle block Although the feasibility of this approach has been studied in healthy volunteers and in a few clinical cases no randomized controlled study has been conducted to determine whether the addition of cutaneous femoral nerve blocks offers an analgesic benefit in the population undergoing total knee replacement surgery This is therefore necessary in order to assess whether this approach improves the clinical trajectory of patients receiving a total knee arthroplasty

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