Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement

Официальное название

Comparative Study Assessing the Efficacy of a Combined Distal Femoral Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty (TKA)

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.
• Процедура Standard perioperative care in both groups
  General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.

Первичные конечные точки

• Postoperative Opioid Consumption in post-anesthesia care unit (PACU). [Срок оценки: From arrival in PACU until discharge from PACU, on postoperative day 0.]

Вторичные конечные точки (10)

• Pain During Regional Anesthesia [Срок оценки: During block administration on postoperative day 0.]
• Postoperative Pain in post-anesthesia care unit (PACU) and Ward [Срок оценки: 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 [Срок оценки: Postoperative day 0 in PACU and postoperative day 1.]
• Time to First Standing [Срок оценки: Postoperative day 0.]
• Postoperative Nausea and Vomiting [Срок оценки: Postoperative day 0 in post-anesthesia care unit (PACU).]
• Oral Opioid Consumption on the Ward [Срок оценки: Postoperative day 1 and until hospital discharge (up to 7 days).]
• Co-analgesic Consumption [Срок оценки: Postoperative day 1 and until hospital discharge (up to 7 days).]
• Intraoperative Medication Use [Срок оценки: Intraoperative period on postoperative day 0.]
• Length of Hospital Stay [Срок оценки: At hospital discharge, up to 7 days after surgery.]
• Patient Satisfaction [Срок оценки: At hospital discharge, up to 7 days after surgery.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hôpital privé Dijon Bourgogne — Dijon

Публикации

• 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.
• 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. PMID 15915023
• 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: 10.1 PMID 35243362
• 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. PMID 26375568
• 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. PMID 32842722
• 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. PMID 28606458

Идентификаторы

NCT: NCT07629388 · COS-RGDS-2025-06-051-P-SANCHEZ · 2025-A02529-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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