Trials / Completed
CompletedNCT06038851
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
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
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Para-Sartorial Compartments (PACS) Block | This intervention was selected because it has the potential to optimize analgesia by skin coverage of the upper third of the surgical incision. The intervention will be performed as follows: * The intermediate femoral cutaneous nerve will be visualized at the supralateral level of the sartorius muscle, in a duplicature of the fascia lata. * The needle will be inserted at the same puncture site as for the femoral triangle block, with a latero-medial orientation in the plane (intracanalar compartment). * In addition to the injection performed in the femoral triangle, two injections of 5 mL of 0.5% ropivacaine + epi 1:400 000 will be performed in addition, below the sartorius muscle (subsartorial compartment) and above the sartorius muscle (suprasartorial compartment). |
| PROCEDURE | Femoral Triangle Block (FTB) | * The high frequency linear ultrasound probe will be positioned midway between the superior edge of the patella and the anterosuperior iliac spine. It will then be moved to visualize the apex of the femoral triangle, confirmed by visualization of the sartorius muscle laterally and the long adductor medially. * The needle will be inserted with a latero-medial orientation in the plane. * The initial injection will be a single injection of 15 ml of 0.5% ropivacaine + epi 1:400 000 under the sartorius muscle, lateral to the femoral artery, at the level of the apex of the femoral triangle. |
| PROCEDURE | Infiltration between popliteal artery and capsule of the knee (IPACK) block | It will be performed in order to block the sensory branches of the innervation posterior to the knee with 15 ml of ropivacaine 0.3% + epi 1:400 000. |
Timeline
- Start date
- 2023-10-02
- Primary completion
- 2025-03-24
- Completion
- 2025-03-31
- First posted
- 2023-09-15
- Last updated
- 2025-07-03
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT06038851. Inclusion in this directory is not an endorsement.