Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement (FEM-COMB)
4 juin 2026 mis à jour par: Ramsay Générale de Santé
Comparative Study Assessing the Efficacy of a Combined Distal Femoral Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty (TKA)
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
240
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Antoine Sanchez
- Numéro de téléphone: +33 3 80 40 01 14
- E-mail: sanchez.antoine@live.fr
Lieux d'étude
-
-
-
Dijon, France, 21000
- Hôpital privé Dijon Bourgogne
-
Contact:
- Antoine SANCHEZ, Dr
- Numéro de téléphone: +33 3 80 40 01 14
- E-mail: sanchez.antoine@live.fr
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Combined Distal Femoral Nerve Block
Participants receive an ultrasound-guided combined distal femoral nerve 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.
They also receive surgical site infiltration, general anesthesia, and standard multimodal analgesia.
|
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.
General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.
|
|
Comparateur actif: Saphenous Nerve Block Alone
Participants receive an 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.
They also receive surgical site infiltration, general anesthesia, and standard multimodal analgesia.
|
General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative Opioid Consumption in post-anesthesia care unit (PACU).
Délai: 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.
|
From arrival in PACU until discharge from PACU, on postoperative day 0.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain During Regional Anesthesia
Délai: 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.
|
During block administration on postoperative day 0.
|
|
Postoperative Pain in post-anesthesia care unit (PACU) and Ward
Délai: 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.
|
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).
|
|
Quadriceps Motor Strength
Délai: 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.
|
Postoperative day 0 in PACU and postoperative day 1.
|
|
Time to First Standing
Délai: Postoperative day 0.
|
Delay until first mobilization/first standing after surgery.
|
Postoperative day 0.
|
|
Postoperative Nausea and Vomiting
Délai: Postoperative day 0 in post-anesthesia care unit (PACU).
|
Incidence of postoperative nausea and vomiting in post-anesthesia care unit (PACU).
|
Postoperative day 0 in post-anesthesia care unit (PACU).
|
|
Oral Opioid Consumption on the Ward
Délai: Postoperative day 1 and until hospital discharge (up to 7 days).
|
Total oral opioid use during hospitalization, reported as oral morphine equivalent.
|
Postoperative day 1 and until hospital discharge (up to 7 days).
|
|
Co-analgesic Consumption
Délai: Postoperative day 1 and until hospital discharge (up to 7 days).
|
Use of co-analgesics including nefopam, paracetamol, opium, and ketoprofen during hospitalization.
|
Postoperative day 1 and until hospital discharge (up to 7 days).
|
|
Intraoperative Medication Use
Délai: Intraoperative period on postoperative day 0.
|
Consumption of hypotensive drugs, vasopressors, and opioids during surgery.
|
Intraoperative period on postoperative day 0.
|
|
Length of Hospital Stay
Délai: At hospital discharge, up to 7 days after surgery.
|
Duration of hospitalization after surgery.
|
At hospital discharge, up to 7 days after surgery.
|
|
Patient Satisfaction
Délai: 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.
|
At hospital discharge, up to 7 days after surgery.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Antoine Sanchez, MD, Hôpital privé Dijon Bourgogne
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Andersen LO, Gaarn-Larsen L, Kristensen BB, Husted H, Otte KS, Kehlet H. Subacute pain and function after fast-track hip and knee arthroplasty. Anaesthesia. 2009 May;64(5):508-13. doi: 10.1111/j.1365-2044.2008.05831.x.
- Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, Francois G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23. doi: 10.1097/00000542-200506000-00010.
- Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.
- Kuang MJ, Ma JX, Fu L, He WW, Zhao J, Ma XL. Is Adductor Canal Block Better Than Femoral Nerve Block in Primary Total Knee Arthroplasty? A GRADE Analysis of the Evidence Through a Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Oct;32(10):3238-3248.e3. doi: 10.1016/j.arth.2017.05.015. Epub 2017 May 17.
- Elkassabany NM, Antosh S, Ahmed M, Nelson C, Israelite C, Badiola I, Cai LF, Williams R, Hughes C, Mariano ER, Liu J. The Risk of Falls After Total Knee Arthroplasty with the Use of a Femoral Nerve Block Versus an Adductor Canal Block: A Double-Blinded Randomized Controlled Study. Anesth Analg. 2016 May;122(5):1696-703. doi: 10.1213/ANE.0000000000001237.
- Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6.
- Wang D, Yang Y, Li Q, Tang SL, Zeng WN, Xu J, Xie TH, Pei FX, Yang L, Li LL, Zhou ZK. Adductor canal block versus femoral nerve block for total knee arthroplasty: a meta-analysis of randomized controlled trials. Sci Rep. 2017 Jan 12;7:40721. doi: 10.1038/srep40721.
- Maurice-Szamburski A. Le vécu périopératoire du patient, un nouveau paradigme ? Le Praticien en Anesthésie Réanimation. déc 2017;21(6):285-9.
- Mahdy EW, Abd El-Hamid AM, Elbarbary DH. Comparison between adductor canal block and femoral nerve block for different knee surgical procedures. A meta-analysis of randomized trials. Egyptian Journal of Anaesthesia. janv 2021;37(1):491-500.
- Tarpin P, Fumery O, Radji M, Martinez V. La chronicisation de la douleur en anesthésie-réanimation. Anesthésie & Réanimation. mars 2025;11(1):36-45.
- Wylde V, Bertram W, Sanderson E, Noble S, Howells N, Peters TJ, Beswick AD, Blom AW, Moore AJ, Bruce J, Walsh DA, Eccleston C, Harris S, Garfield K, White S, Toms A, Gooberman-Hill R; STAR trial group. The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial. Lancet Rheumatol. 2022 Jan 28;4(3):e188-e197. doi: 10.1016/S2665-9913(21)00371-4. eCollection 2022 Mar.
- Mei S, Jin S, Chen Z, Ding X, Zhao X, Li Q. Analgesia for total knee arthroplasty: a meta-analysis comparing local infiltration and femoral nerve block. Clinics (Sao Paulo). 2015 Sep;70(9):648-53. doi: 10.6061/clinics/2015(09)09.
- Gadsden JC, Sata S, Bullock WM, Kumar AH, Grant SA, Dooley JR. The relative analgesic value of a femoral nerve block versus adductor canal block following total knee arthroplasty: a randomized, controlled, double-blinded study. Korean J Anesthesiol. 2020 Oct;73(5):417-424. doi: 10.4097/kja.20269. Epub 2020 Aug 26.
- Nicolino TI, Costantini J, Carbo L. Complementary Saphenous Nerve Block to Intra-Articular Analgesia Reduces Pain After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial. J Arthroplasty. 2020 Jun;35(6S):S168-S172. doi: 10.1016/j.arth.2020.03.010. Epub 2020 Mar 12.
- Knecht S, Tamine L, Faure N, Tran P, Orban JC, Bronsard N, Gonzalez JF, Micicoi G. Effectiveness of adductor canal block combined with posterior capsular infiltration on pain and return to walking after total knee arthroplasty: comparative analysis with femoral and popliteal sciatic nerves blocks. Orthop Traumatol Surg Res. 2025 Sep;111(5):104082. doi: 10.1016/j.otsr.2024.104082. Epub 2024 Dec 5.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
25 mai 2026
Achèvement primaire (Estimé)
25 mai 2027
Achèvement de l'étude (Estimé)
25 mai 2027
Dates d'inscription aux études
Première soumission
27 mai 2026
Première soumission répondant aux critères de contrôle qualité
4 juin 2026
Première publication (Réel)
5 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 juin 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- COS-RGDS-2025-06-051-P-SANCHEZ
- 2025-A02529-40 (Autre identifiant: ID-RCB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual participant data underlying the results reported in the published article will be made available, together with the study protocol and statistical analysis plan, after publication of the main results.
Data sharing will be subject to sponsor approval, a methodologically sound proposal, signature of a data access agreement, and compliance with GDPR.
Délai de partage IPD
Beginning 6 months and ending 36 months after publication of the main results
Critères d'accès au partage IPD
Requests should be addressed to the corresponding author and will be reviewed by the sponsor; data will be shared with researchers providing a methodologically sound proposal, after signature of a data access agreement and in compliance with GDPR.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .