Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche
About this trial
The goal of this clinical trial is to see whether a combined distal femoral nerve block improves pain relief after total knee replacement in adults having planned surgery. The main questions it aims to answer are:
* Does the combined distal femoral nerve block reduce the amount of opioid needed in the post-anesthesia recovery room? * Does it preserve quadriceps muscle strength while improving postoperative pain control?
Researchers will compare the combined distal femoral nerve block to a saphenous nerve block alone to see if the combined block provides better analgesia without reducing leg strength.
Participants will:
* Receive either the combined distal femoral nerve block or the saphenous nerve block alone before surgery. * Also receive standard multimodal pain management, including anesthesia, surgical site infiltration, and postoperative pain medications. * Be assessed for pain, opioid use, nausea and vomiting, quadriceps strength, time to first standing, hospital stay length, and patient satisfaction from surgery until discharge.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged over 18 years.
Scheduled for total knee arthroplasty with multimodal analgesia.
Affiliated with or benefiting from a social security system.
Able to understand the study information and provide written informed consent.
Disqualifiers
Emergency surgery.
Weight under 50 kg.
Body mass index over 40 kg/m².
Contraindication to nefopam, non-steroidal anti-inflammatory drugs, local anesthetics, or morphine.
Trial design
Design model
Parallel
Treatments tested in this trial
Combined distal femoral nerve block
Procedure/SurgeryUltrasound-guided block targeting the saphenous nerve, vastus medialis nerve, and anterior femoral cutaneous nerves, using ropivacaine 2 mg/mL, 40 mL total, with clonidine 30 micrograms perineural and dexamethasone 8 mg IV.
Saphenous nerve block alone
Procedure/SurgeryUltrasound-guided saphenous nerve block at the adductor canal, using ropivacaine 2 mg/mL, 20 mL total, with clonidine 30 micrograms perineural and dexamethasone 8 mg IV.
Standard perioperative care in both groups
Procedure/SurgeryGeneral anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Combined Distal Femoral Nerve BlockExperimental treatment 2 interventions
Group B: Saphenous Nerve Block AloneActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Postoperative Opioid Consumption in post-anesthesia care unit (PACU).
Total amount of opioids consumed in the post-anesthesia care unit, converted into oral morphine equivalent.
Time frame
From arrival in PACU until discharge from PACU, on postoperative day 0.Secondary outcomes
1
Pain During Regional Anesthesia
Pain experienced during the performance of the locoregional anesthesia, assessed using a 10-point visual analog scale (VAS), in which 0 indicates no pain and 10 indicates maximal pain.
Time frame
During block administration on postoperative day 0.2
Postoperative Pain in post-anesthesia care unit (PACU) and Ward
Pain intensity measured with a 10-point visual analog scale (VAS), in which 0 indicates no pain and 10 indicates maximal pain.
Time frame
Twice in PACU on postoperative day 0 after extubation and before PACU discharge; three times on postoperative day 1; and at hospital discharge (up to 7 days).3
Quadriceps Motor Strength
Quadriceps motor strength will be assessed using the Medical Research Council muscle strength scale, ranging from 0 to 5, where 0 indicates no visible contraction and 5 indicates normal strength; higher scores indicate better motor strength. Ability to perform an active straight-leg raise will be recorded as yes/no, and quadriceps tone will be clinically assessed for hypotonia, flaccidity, or contracture.
Time frame
Postoperative day 0 in PACU and postoperative day 1.4
Time to First Standing
Delay until first mobilization/first standing after surgery.
Time frame
Postoperative day 0.Sponsors and contacts
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Source ClinicalTrials.gov