Pain After Total Knee Arthroplasty, Pain Management
Conditions
Keywords
total knee arthroplasty, distal femoral nerve block, saphenous nerve block, femoral triangle block, postoperative pain, opioid consumption, regional anesthesia
Brief summary
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.
Interventions
PROCEDURECombined distal femoral nerve block
Ultrasound-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.
PROCEDURESaphenous nerve block alone
Ultrasound-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.
PROCEDUREStandard perioperative care in both groups
General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.
Sponsors
Ramsay Générale de Santé
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Preoperative opioid use. * Antidepressant or gabapentinoid treatment. * Other planned surgical or medical procedures during the study period. * Participation in another clinical trial, or currently in an exclusion period from another trial. * Inability to understand study information for linguistic, psychological, cognitive, or literacy reasons. * Pregnancy, possible pregnancy without effective contraception, or breastfeeding. * Protected adults, including those under guardianship, curatorship, legal protection, detention, or otherwise unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Consumption in post-anesthesia care unit (PACU). | From arrival in PACU until discharge from PACU, on postoperative day 0. | Total amount of opioids consumed in the post-anesthesia care unit, converted into oral morphine equivalent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain During Regional Anesthesia | During block administration on postoperative day 0. | 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. |
| Postoperative Pain in post-anesthesia care unit (PACU) and Ward | 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). | Pain intensity measured with a 10-point visual analog scale (VAS), in which 0 indicates no pain and 10 indicates maximal pain. |
| Quadriceps Motor Strength | Postoperative day 0 in PACU and postoperative day 1. | 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 to First Standing | Postoperative day 0. | Delay until first mobilization/first standing after surgery. |
| Postoperative Nausea and Vomiting | Postoperative day 0 in post-anesthesia care unit (PACU). | Incidence of postoperative nausea and vomiting in post-anesthesia care unit (PACU). |
| Oral Opioid Consumption on the Ward | Postoperative day 1 and until hospital discharge (up to 7 days). | Total oral opioid use during hospitalization, reported as oral morphine equivalent. |
| Co-analgesic Consumption | Postoperative day 1 and until hospital discharge (up to 7 days). | Use of co-analgesics including nefopam, paracetamol, opium, and ketoprofen during hospitalization. |
| Intraoperative Medication Use | Intraoperative period on postoperative day 0. | Consumption of hypotensive drugs, vasopressors, and opioids during surgery. |
| Length of Hospital Stay | At hospital discharge, up to 7 days after surgery. | Duration of hospitalization after surgery. |
| Patient Satisfaction | At hospital discharge, up to 7 days after surgery. | Patient satisfaction will be assessed using the Evaluation du Vécu de l'Anesthésie Générale (EVAN-G), a validated 26-item self-administered perioperative satisfaction questionnaire. The EVAN-G includes six dimensions: attention, privacy, information, pain, discomfort, and waiting times. The global satisfaction index score ranges from 0 to 100, where 0 indicates the worst possible level of satisfaction and 100 indicates the best possible level of satisfaction; higher scores indicate greater patient satisfaction. |
Countries
France
Contacts
CONTACTAntoine Sanchez
PRINCIPAL_INVESTIGATORAntoine Sanchez, MD
Hôpital privé Dijon Bourgogne
Outcome results
None listed