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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02529-40 | Other Identifier | ID-RCB |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Distal Femoral Nerve Block | Experimental | 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. |
|
| Saphenous Nerve Block Alone | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined distal femoral nerve block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Opioid Consumption in post-anesthesia care unit (PACU). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain During Regional Anesthesia | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine Sanchez | Contact | +33 3 80 40 01 14 | sanchez.antoine@live.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine Sanchez, MD | Hôpital privé Dijon Bourgogne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital privé Dijon Bourgogne | Dijon | 21000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Maurice-Szamburski A. Le vécu périopératoire du patient, un nouveau paradigme ? Le Praticien en Anesthésie Réanimation. déc 2017;21(6):285-9. | ||
| Background | 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. | ||
| Background | Tarpin P, Fumery O, Radji M, Martinez V. La chronicisation de la douleur en anesthésie-réanimation. Anesthésie & Réanimation. mars 2025;11(1):36-45. | ||
| 15915023 | Background | 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. |
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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.
Beginning 6 months and ending 36 months after publication of the main results
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.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Saphenous nerve block alone | Procedure | 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. |
|
| Standard perioperative care in both groups | Procedure | General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen. |
|
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 | 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 | Delay until first mobilization/first standing after surgery. | Postoperative day 0. |
| Postoperative Nausea and Vomiting | 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 | 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 | 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 | Consumption of hypotensive drugs, vasopressors, and opioids during surgery. | Intraoperative period on postoperative day 0. |
| Length of Hospital Stay | Duration of hospitalization after surgery. | At hospital discharge, up to 7 days after surgery. |
| Patient Satisfaction | 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. |
| 35243362 | Background | 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. |
| 26375568 | Background | 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. |
| 32842722 | Background | 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. |
| 28606458 | Background | 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. |
| 28079176 | Background | 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. |
| 27007076 | Background | 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. |
| 19413820 | Background | 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. |
| 32253065 | Background | 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. |
| 39645191 | Background | 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. |
| 22357571 | Background | 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. |
| 30983589 | Background | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |