Total Knee Arthroplasty
Conditions
Keywords
Knee arthroplasty, Local Infiltration Analgesia, Regional anesthesia, Ropivacaine, Postoperative analgesia, Pain management, Opioids
Brief 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.
Interventions
PROCEDURESurgical 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
PROCEDUREObturator 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
PROCEDUREFemoral nerve block
Injection of 15 mL of 0.1% ropivacaine under the fascia iliaca, with the patient in supine position
PROCEDURESciatic nerve block
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
Sponsors
CMC Ambroise Paré
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption within 24 hours | From start of surgery (t0) to 24 hours postoperatively | Total cumulative opioid consumption during the first 24 hours, expressed in oral morphine equivalents (OME, mg), including intraoperative and postoperative opioid administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative anesthetic consumption | During surgery | Total intraoperative consumption of propofol (mg) |
| Intraoperative opioid consumption | During surgery | Total intraoperative consumption of sufentanil (µg) |
| Intraoperative hypertension events | During surgery | Occurrence of intraoperative hypertension episodes defined as systolic blood pressure \>160 mmHg |
| Intraoperative hypotension events | During surgery | Occurrence of intraoperative hypotension episodes defined as systolic blood pressure \<90 mmHg |
| Postoperative pain intensity | Up to 48 hours postoperatively | 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 |
| Total opioid consumption within 48 hours | From start of surgery (t0) to 48 hours postoperatively | Total cumulative opioid consumption during the first 48 hours, expressed in oral morphine equivalents (OME, mg), including intraoperative and postoperative opioid administration. |
| Opioid-related adverse effects | Up to 48 hours postoperatively | Incidence of nausea and vomiting, somnolence, constipation, acute urinary retention, pruritus, and disorientation. |
| Quadricep motor function | Postoperative days 0, 1, and 2 | Quadriceps muscle strength assessed on a 3-point scale: 0 = paralysis; 1 = paresis; 2 = normal contraction |
| Foot elevator muscle motor function | Postoperative days 0, 1, and 2 | Ankle dorsiflexor muscle strength assessed on a 3-point scale: 0 = paralysis; 1 = paresis; 2 = normal contraction |
| Ability to stand and walk | Postoperative days 0, 1, and 2 | 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 |
| Mobility and balance | Postoperative days 0, 1, and 2 | Timed Up and Go (TUG) test, measured in seconds |
| Functional Independence | Postoperative days 0, 1, and 2 | Functional Independence Measure (FIM), with total scores ranging from 18 to 126, where higher scores indicating greater independence |
| Postoperative falls | Postoperative days 0, 1, and 2 | Occurrence of any fall defined as an unintentional event resulting in the patient coming to rest on the ground or a lower level |
| Hospital readmission within 30 days | 30 days postoperatively | Any hospital readmission within 30 days after surgery, regardless of cause |
| Functional outcome at 60 days | 60 days postoperatively | Short-form WOMAC index focused on physical function), with total scores ranging from 0 to 28, where higher scores indicating greater functional impairment |
Countries
France
Contacts
CONTACTPhilippe MARTY, MD
Outcome results
None listed