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

NCT06038851 | Completed

• 1 other identifier: 23.116
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-operative Pain; Anesthesia, Local

Keywords

total knee replacement surgery; para-sartorial compartments block; femoral triangle block

Outcome Measures

Primary Outcomes (1)

• Intensity of the postoperative pain

  The Pain Intensity short form questionnaire (PROMIS) is universal rather than disease-specific. The first two items in the Pain Intensity item bank assess pain intensity utilizing a 24-hour recall period (items include the phrase "the past 24 hours") while the last item asks patient to rate their pain intensity "right now."

  24 hours after the surgery

Secondary Outcomes (8)

• Intensity of the postoperative pain

  7 days after the surgery

• Total morphine consumption

  24 hours after the surgery

• Time between the end of surgery and the first opioid dose

  24 hours after the surgery

• Pain levels

  6 hours, 12 hours, 18 hours and 24 hours after the surgery

• Complications

  24 hours after the surgery

Study Arms (2)

Para-Sartorial Compartment (PACS) Block + Femoral Triangle Block (FTB) + IPACK block

EXPERIMENTAL

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 below the sartorius muscle (subsartorial compartment) and above the sartorius muscle (suprasartorial compartment). For all patients, an infiltration between popliteal artery and capsule of the knee block (IPACK) will be performed concomitantly, 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.

Procedure: Para-Sartorial Compartments (PACS) Block; Procedure: Femoral Triangle Block (FTB); Procedure: Infiltration between popliteal artery and capsule of the knee (IPACK) block

Femoral Triangle Block (FTB) + IPACK block

ACTIVE COMPARATOR

This block is currently the most used in practice and is considered a standard of care. It consists of 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 For all patients, an infiltration between popliteal artery and capsule of the knee block (IPACK) will be performed concomitantly, 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.

Procedure: Femoral Triangle Block (FTB); Procedure: Infiltration between popliteal artery and capsule of the knee (IPACK) block

Interventions

Para-Sartorial Compartments (PACS) Block PROCEDURE

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).

Para-Sartorial Compartment (PACS) Block + Femoral Triangle Block (FTB) + IPACK block

Femoral Triangle Block (FTB) PROCEDURE

* 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.

Femoral Triangle Block (FTB) + IPACK block; Para-Sartorial Compartment (PACS) Block + Femoral Triangle Block (FTB) + IPACK block

Infiltration between popliteal artery and capsule of the knee (IPACK) block PROCEDURE

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.

Femoral Triangle Block (FTB) + IPACK block; Para-Sartorial Compartment (PACS) Block + Femoral Triangle Block (FTB) + IPACK block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over, requiring a primary total knee arthroplasty
• 'American Society of Anesthesiologists' classification 1 to 3

You may not qualify if:

• Refusal or unable to consent
• Contraindications to a peripheral nerve block;
• Inability to communicate with the healthcare team or the research team;
• Inability to understand follow-up instructions or questionnaires;
• Chronic pain requiring the intake of the equivalent of more than 60 mg of morphine daily;
• Pregnancy;
• Patients weighing less than 50 kg (to limit the risk of intoxication with local anesthetics).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Maxim Roy, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective superiority study, randomized controlled, triple blind

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 15, 2023
• Study Start: October 2, 2023
• Primary Completion: March 24, 2025
• Study Completion: March 31, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)