Local Infiltration Analgesia Versus Quadruple Nerve Blocks in Total Knee Arthroplasty.
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical local infiltration, Obturator nerve block, Femoral nerve block, Sciatic nerve block.
- Who it may be relevant to
- Registry conditions: Total Knee Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Local Infiltration Analgesia Versus Quadruple Nerve Blocks in Total Knee Arthroplasty: a Randomized Controlled Trial.
Overview
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.
Interventions
- 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
Primary outcome measures
- Total opioid consumption within 24 hours [Time frame: From start of surgery (t0) to 24 hours postoperatively]
Secondary outcome measures (12)
- Intraoperative anesthetic consumption [Time frame: During surgery]
- Intraoperative opioid consumption [Time frame: During surgery]
- Intraoperative hypertension events [Time frame: During surgery]
- Intraoperative hypotension events [Time frame: During surgery]
- Postoperative pain intensity [Time frame: Up to 48 hours postoperatively]
- Total opioid consumption within 48 hours [Time frame: From start of surgery (t0) to 48 hours postoperatively]
- Opioid-related adverse effects [Time frame: Up to 48 hours postoperatively]
- Quadricep motor function [Time frame: Postoperative days 0, 1, and 2]
- Foot elevator muscle motor function [Time frame: Postoperative days 0, 1, and 2]
- Ability to stand and walk [Time frame: Postoperative days 0, 1, and 2]
- Mobility and balance [Time frame: Postoperative days 0, 1, and 2]
- Functional Independence [Time frame: Postoperative days 0, 1, and 2]
Eligibility criteria
Inclusion criteria
- Patients undergoing primary total knee arthroplasty under general anesthesia (laryngeal mask airway)
- Fully autonomous at home
- Planned discharge to home
- Consent for participation
- Affiliation to a social security system
Exclusion criteria
- Preoperative opioid use
- Chronic pain syndrome
- Valgus contraindicating sciatic nerve block
- Contraindication to any drugs used in the protocol
- Contraindication to laryngeal mask airway
- Pregnant or breastfeeding women
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
France · 1 center
- Clinique Médipôle Garonne — Toulouse
Identifiers
NCT: NCT07477730 · 2025/02