Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement (FEM-COMB)
4. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Intervensjonell
Registrering (Antatt)
240
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Antoine Sanchez
- Telefonnummer: +33 3 80 40 01 14
- E-post: sanchez.antoine@live.fr
Studiesteder
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Dijon, Frankrike, 21000
- Hôpital privé Dijon Bourgogne
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Ta kontakt med:
- Antoine SANCHEZ, Dr
- Telefonnummer: +33 3 80 40 01 14
- E-post: sanchez.antoine@live.fr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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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.
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Aktiv komparator: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Postoperative Opioid Consumption in post-anesthesia care unit (PACU).
Tidsramme: From arrival in PACU until discharge from PACU, on postoperative day 0.
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Total amount of opioids consumed in the post-anesthesia care unit, converted into oral morphine equivalent.
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From arrival in PACU until discharge from PACU, on postoperative day 0.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain During Regional Anesthesia
Tidsramme: During block administration on postoperative day 0.
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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.
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During block administration on postoperative day 0.
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Postoperative Pain in post-anesthesia care unit (PACU) and Ward
Tidsramme: 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).
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Pain intensity measured with a 10-point visual analog scale (VAS), in which 0 indicates no pain and 10 indicates maximal pain.
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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).
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Quadriceps Motor Strength
Tidsramme: Postoperative day 0 in PACU and postoperative day 1.
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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.
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Postoperative day 0 in PACU and postoperative day 1.
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Time to First Standing
Tidsramme: Postoperative day 0.
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Delay until first mobilization/first standing after surgery.
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Postoperative day 0.
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Postoperative Nausea and Vomiting
Tidsramme: Postoperative day 0 in post-anesthesia care unit (PACU).
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Incidence of postoperative nausea and vomiting in post-anesthesia care unit (PACU).
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Postoperative day 0 in post-anesthesia care unit (PACU).
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Oral Opioid Consumption on the Ward
Tidsramme: Postoperative day 1 and until hospital discharge (up to 7 days).
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Total oral opioid use during hospitalization, reported as oral morphine equivalent.
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Postoperative day 1 and until hospital discharge (up to 7 days).
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Co-analgesic Consumption
Tidsramme: Postoperative day 1 and until hospital discharge (up to 7 days).
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Use of co-analgesics including nefopam, paracetamol, opium, and ketoprofen during hospitalization.
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Postoperative day 1 and until hospital discharge (up to 7 days).
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Intraoperative Medication Use
Tidsramme: Intraoperative period on postoperative day 0.
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Consumption of hypotensive drugs, vasopressors, and opioids during surgery.
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Intraoperative period on postoperative day 0.
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Length of Hospital Stay
Tidsramme: At hospital discharge, up to 7 days after surgery.
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Duration of hospitalization after surgery.
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At hospital discharge, up to 7 days after surgery.
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Patient Satisfaction
Tidsramme: At hospital discharge, up to 7 days after surgery.
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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.
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At hospital discharge, up to 7 days after surgery.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Antoine Sanchez, MD, Hôpital privé Dijon Bourgogne
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
25. mai 2026
Primær fullføring (Antatt)
25. mai 2027
Studiet fullført (Antatt)
25. mai 2027
Datoer for studieregistrering
Først innsendt
27. mai 2026
Først innsendt som oppfylte QC-kriteriene
4. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- COS-RGDS-2025-06-051-P-SANCHEZ
- 2025-A02529-40 (Annen identifikator: ID-RCB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Beginning 6 months and ending 36 months after publication of the main results
Tilgangskriterier for IPD-deling
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.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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