An interventional study of Surgical local infiltration and Obturator nerve block in Total Knee Arthroplasty, sponsored by CMC Ambroise Paré. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by CMC Ambroise Paré · Not applicable, Interventional, and Other
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:
CMC Ambroise Paré is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Local infiltration analgesia
Procedure: Surgical local infiltration
Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks
Procedure: Obturator nerve block · Procedure: Femoral nerve block · Procedure: Sciatic nerve block · Procedure: Lateral femoral cutaneous nerve block
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
Injection of 20 mL of 0.1% ropivacaine between the adductor magnus and adductor brevis muscles and between the adductor brevis and pectineus muscles
Injection of 15 mL of 0.1% ropivacaine under the fascia iliaca, with the patient in supine position
Injection of 20 mL of 0.1% ropivacaine in the subgluteal space via a lateral approach, with the patient in prone position
Injection of 5 mL of 0.1% ropivacaine lateral to the sartorius muscle
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.
Time frame: From start of surgery (t0) to 24 hours postoperatively
Intraoperative anesthetic consumption
Total intraoperative consumption of propofol (mg)
Time frame: During surgery
Intraoperative opioid consumption
Total intraoperative consumption of sufentanil (µg)
Time frame: During surgery
Intraoperative hypertension events
Occurrence of intraoperative hypertension episodes defined as systolic blood pressure \>160 mmHg
Time frame: During surgery
Intraoperative hypotension events
Occurrence of intraoperative hypotension episodes defined as systolic blood pressure \<90 mmHg
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to 48 hours postoperatively
Quadricep motor function
Quadriceps muscle strength assessed on a 3-point scale: 0 = paralysis; 1 = paresis; 2 = normal contraction
Time frame: 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
Time frame: 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
Time frame: Postoperative days 0, 1, and 2
Mobility and balance
Timed Up and Go (TUG) test, measured in seconds
Time frame: 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
Time frame: 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
Time frame: Postoperative days 0, 1, and 2
Hospital readmission within 30 days
Any hospital readmission within 30 days after surgery, regardless of cause
Time frame: 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
Time frame: 60 days postoperatively
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Agnosia
CMC Ambroise Paré