Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement (FEM-COMB)
2026年6月4日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
240
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Antoine Sanchez
- 電話番号：+33 3 80 40 01 14
- メール：sanchez.antoine@live.fr
研究場所
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Dijon、フランス、21000
- Hôpital privé Dijon Bourgogne
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コンタクト：
- Antoine SANCHEZ, Dr
- 電話番号：+33 3 80 40 01 14
- メール：sanchez.antoine@live.fr
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative Opioid Consumption in post-anesthesia care unit (PACU).
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain During Regional Anesthesia
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Antoine Sanchez, MD、Hôpital privé Dijon Bourgogne
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月25日
一次修了 (推定)
2027年5月25日
研究の完了 (推定)
2027年5月25日
試験登録日
最初に提出
2026年5月27日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月5日
QC基準を満たした最後の更新が送信されました
2026年6月4日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- COS-RGDS-2025-06-051-P-SANCHEZ
- 2025-A02529-40 (その他の識別子：ID-RCB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Beginning 6 months and ending 36 months after publication of the main results
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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いいえ
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