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Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedures and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.
Optimal postoperative pain management after TKA is not fully defined. While multimodal analgesia is standard, the choice of associated regional anesthesia techniques is debated.
Local infiltration analgesia (LIA) is widely used and provides effective pain relief without impairing early mobilization.
Peripheral nerve blocks have been discussed due to the risk of motor blockade, but low-concentration local anesthetics, such as 0.1% ropivacaine, allow sensory blockade while preserving motor function. Preliminary studies suggest that this concentration is effective and safe.
The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to compare the analgesic efficacy of a quadruple nerve blocks (femoral, sciatic, obturator, and lateral femoral cutaneous nerves) using 0.1% ropivacaine versus standard LIA in patients undergoing TKA.
In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to the recommendations of the SFAR (French Society of Anesthesia & Intensive Care Medecine) and an injection of 10 mg of IV dexamethasone.
The surgical procedure is a total knee arthroplasty (TKA) performed under general anesthesia (GA) with a laryngeal mask. The only difference between the two groups will be the site and technique of local anesthetic (LA) injection.
The patients will be randomized into two groups:
In the operating room, general anesthesia will be induced with intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). Anesthesia will be maintained with propofol.
Other medications administered intraoperatively:
Postoperative analgesia protocol:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIA group | Active Comparator | Local infiltration analgesia |
|
| Quadruple nerve blocks group | Experimental | Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical local infiltration | Procedure | Injection of 150 mL of ropivacaine 0.2% into periarticular tissues according to a standardized sequence, including the posterior capsule, collateral ligaments, quadriceps, patellar tendon, capsule and subcutaneous tissue before wound closure |
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid consumption within 24 hours | Total cumulative opioid consumption during the first 24 hours, expressed in oral morphine equivalents (OME, mg), including intraoperative and postoperative opioid administration. | From start of surgery (t0) to 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative anesthetic consumption | Total intraoperative consumption of propofol (mg) | During surgery |
| Intraoperative opioid consumption | Total intraoperative consumption of sufentanil (µg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe MARTY, MD | Contact | 05 62 13 29 97 | 33 | philippemarty@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Médipôle Garonne | Toulouse | Haute-Garonne | 31036 | France |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Obturator nerve block | Procedure | Injection of 20 mL of 0.1% ropivacaine between the adductor magnus and adductor brevis muscles and between the adductor brevis and pectineus muscles |
|
| Femoral nerve block | Procedure | Injection of 15 mL of 0.1% ropivacaine under the fascia iliaca, with the patient in supine position |
|
| Sciatic nerve block | Procedure | Injection of 20 mL of 0.1% ropivacaine in the subgluteal space via a lateral approach, with the patient in prone position |
|
| Lateral femoral cutaneous nerve block | Procedure | Injection of 5 mL of 0.1% ropivacaine lateral to the sartorius muscle |
|
| During surgery |
| Intraoperative hypertension events | Occurrence of intraoperative hypertension episodes defined as systolic blood pressure >160 mmHg | During surgery |
| Intraoperative hypotension events | Occurrence of intraoperative hypotension episodes defined as systolic blood pressure <90 mmHg | During surgery |
| Postoperative pain intensity | Pain intensity at rest assessed using a verbal rating scale (VRS, 0-10) ranging from 0 to 10 (0=no pain, 10=worst possible pain), recorded every 6 hours during the first 48 postoperative hours | Up to 48 hours postoperatively |
| Total opioid consumption within 48 hours | Total cumulative opioid consumption during the first 48 hours, expressed in oral morphine equivalents (OME, mg), including intraoperative and postoperative opioid administration. | From start of surgery (t0) to 48 hours postoperatively |
| Opioid-related adverse effects | Incidence of nausea and vomiting, somnolence, constipation, acute urinary retention, pruritus, and disorientation. | Up to 48 hours postoperatively |
| Quadricep motor function | Quadriceps muscle strength assessed on a 3-point scale: 0 = paralysis; 1 = paresis; 2 = normal contraction | Postoperative days 0, 1, and 2 |
| Foot elevator muscle motor function | Ankle dorsiflexor muscle strength assessed on a 3-point scale: 0 = paralysis; 1 = paresis; 2 = normal contraction | Postoperative days 0, 1, and 2 |
| Ability to stand and walk | 4-point scale: 0 = unable to get up; 1 = able to get up but unable to walk; 2 = able to walk <50 m; 3 = able to walk ≥50 m | Postoperative days 0, 1, and 2 |
| Mobility and balance | Timed Up and Go (TUG) test, measured in seconds | Postoperative days 0, 1, and 2 |
| Functional Independence | Functional Independence Measure (FIM), with total scores ranging from 18 to 126, where higher scores indicating greater independence | Postoperative days 0, 1, and 2 |
| Postoperative falls | Occurrence of any fall defined as an unintentional event resulting in the patient coming to rest on the ground or a lower level | Postoperative days 0, 1, and 2 |
| Hospital readmission within 30 days | Any hospital readmission within 30 days after surgery, regardless of cause | 30 days postoperatively |
| Functional outcome at 60 days | Short-form WOMAC index focused on physical function), with total scores ranging from 0 to 28, where higher scores indicating greater functional impairment | 60 days postoperatively |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |