Trials / Not Yet Recruiting
Not Yet RecruitingNCT07477730
Local Infiltration Analgesia Versus Quadruple Nerve Blocks in Total Knee Arthroplasty.
Local Infiltration Analgesia Versus Quadruple Nerve Blocks in Total Knee Arthroplasty: a Randomized Controlled Trial.
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- CMC Ambroise Paré · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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: * LIA group (usual technique): surgical local infiltration * Quadruple nerve blocks group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks 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: * Tranexamic acid (1 g) * Uradipil (5 mg every 3 minutes) if systolic blood pressure (SBP) \> 160 mmHg * Norepinephrine (10 µg every 3 minutes) or Ephedrine (6 mg every 3 minutes) if SBP \< 90 mmHg * Sufentanil (initial dose of 5 µg, then 5 µg every 5 minutes as needed at the anesthesiologist's discretion) Postoperative analgesia protocol: * Multimodal analgesia will be instituted from the end of the surgery by the administration of paracetamol (1 g) and ketoprofen (100 mg). * In post-anesthesia care unit (PACU): oxycodone titration if VRS (pain score) \>3 according to the centre's usual care. * In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day), oxycodone (10 mg, lockout interval: 4 h) if VRS (pain score) \>3 and cryotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Surgical local infiltration | 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 |
| PROCEDURE | Obturator nerve block | Injection of 20 mL of 0.1% ropivacaine between the adductor magnus and adductor brevis muscles and between the adductor brevis and pectineus muscles |
| PROCEDURE | Femoral nerve block | Injection of 15 mL of 0.1% ropivacaine under the fascia iliaca, with the patient in supine position |
| PROCEDURE | Sciatic nerve block | Injection of 20 mL of 0.1% ropivacaine in the subgluteal space via a lateral approach, with the patient in prone position |
| PROCEDURE | Lateral femoral cutaneous nerve block | Injection of 5 mL of 0.1% ropivacaine lateral to the sartorius muscle |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2027-12-02
- Completion
- 2028-02-01
- First posted
- 2026-03-17
- Last updated
- 2026-03-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT07477730. Inclusion in this directory is not an endorsement.