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Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement (FEM-COMB)

4. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

240

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Dijon, Frankrig, 21000
        • Hôpital privé Dijon Bourgogne
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Combined 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.
Procedure: Standard perioperative care in both groups
General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.
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.
Procedure: Standard perioperative care in both groups
General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.
Procedure: Saphenous 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Opioid Consumption in post-anesthesia care unit (PACU).
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain During Regional Anesthesia
Tidsramme: 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
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).
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
Tidsramme: 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
Tidsramme: Postoperative day 0.
Delay until first mobilization/first standing after surgery.
Postoperative day 0.
Postoperative Nausea and Vomiting
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ramsay Générale de Santé

Efterforskere

  • Ledende efterforsker: Antoine Sanchez, MD, Hôpital privé Dijon Bourgogne

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. maj 2026

Primær færdiggørelse (Anslået)

25. maj 2027

Studieafslutning (Anslået)

25. maj 2027

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • COS-RGDS-2025-06-051-P-SANCHEZ
  • 2025-A02529-40 (Anden identifikator: ID-RCB)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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