- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477730
Local Infiltration Analgesia Versus Quadruple Nerve Blocks in Total Knee Arthroplasty. (LIAQ)
Local Infiltration Analgesia Versus Quadruple Nerve Blocks in Total Knee Arthroplasty: a Randomized Controlled Trial.
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Philippe MARTY, MD
- Phone Number: 33 05 62 13 29 97
- Email: philippemarty@hotmail.com
Study Locations
-
-
Haute-Garonne
-
Toulouse, Haute-Garonne, France, 31036
- Clinique MEDIPOLE GARONNE
-
Contact:
- Clément CHASSERY, MD
- Phone Number: 33 05 62 13 29 97
- Email: cchassery@gmail.com
-
Principal Investigator:
- Clément CHASSERY, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: LIA group
Local infiltration analgesia
|
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
|
|
Experimental: Quadruple nerve blocks group
Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total opioid consumption within 24 hours
Time Frame: 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.
|
From start of surgery (t0) to 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative anesthetic consumption
Time Frame: During surgery
|
Total intraoperative consumption of propofol (mg)
|
During surgery
|
|
Intraoperative opioid consumption
Time Frame: During surgery
|
Total intraoperative consumption of sufentanil (µg)
|
During surgery
|
|
Intraoperative hypertension events
Time Frame: During surgery
|
Occurrence of intraoperative hypertension episodes defined as systolic blood pressure >160 mmHg
|
During surgery
|
|
Intraoperative hypotension events
Time Frame: During surgery
|
Occurrence of intraoperative hypotension episodes defined as systolic blood pressure <90 mmHg
|
During surgery
|
|
Postoperative pain intensity
Time Frame: 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
|
Up to 48 hours postoperatively
|
|
Total opioid consumption within 48 hours
Time Frame: 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.
|
From start of surgery (t0) to 48 hours postoperatively
|
|
Opioid-related adverse effects
Time Frame: Up to 48 hours postoperatively
|
Incidence of nausea and vomiting, somnolence, constipation, acute urinary retention, pruritus, and disorientation.
|
Up to 48 hours postoperatively
|
|
Quadricep motor function
Time Frame: Postoperative days 0, 1, and 2
|
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
Time Frame: Postoperative days 0, 1, and 2
|
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
Time Frame: 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
|
Postoperative days 0, 1, and 2
|
|
Mobility and balance
Time Frame: Postoperative days 0, 1, and 2
|
Timed Up and Go (TUG) test, measured in seconds
|
Postoperative days 0, 1, and 2
|
|
Functional Independence
Time Frame: 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 days 0, 1, and 2
|
|
Postoperative falls
Time Frame: 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
|
Postoperative days 0, 1, and 2
|
|
Hospital readmission within 30 days
Time Frame: 30 days postoperatively
|
Any hospital readmission within 30 days after surgery, regardless of cause
|
30 days postoperatively
|
|
Functional outcome at 60 days
Time Frame: 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
|
60 days postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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