Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement

NCT07629388 | Not Yet Recruiting

• 2 other identifiers: COS-RGDS-2025-06-051-P-SANCHEZ2025-A02529-40
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain After Total Knee Arthroplasty; Pain Management

Keywords

total knee arthroplasty; distal femoral nerve block; saphenous nerve block; femoral triangle block; postoperative pain; opioid consumption; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (10)

• Pain During Regional Anesthesia

  During block administration on postoperative day 0.

• Postoperative Pain in post-anesthesia care unit (PACU) and Ward

  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

  Postoperative day 0 in PACU and postoperative day 1.

• Time to First Standing

  Postoperative day 0.

• Postoperative Nausea and Vomiting

  Postoperative day 0 in post-anesthesia care unit (PACU).

Study Arms (2)

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.

Procedure: Combined distal femoral nerve block; Procedure: Standard perioperative care in both groups

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.

Procedure: Saphenous nerve block alone; Procedure: Standard perioperative care in both groups

Interventions

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.

Combined Distal Femoral Nerve Block

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.

Saphenous Nerve Block Alone

Standard perioperative care in both groups PROCEDURE

General anesthesia, surgical site infiltration, and multimodal analgesia with paracetamol, nefopam, and ketoprofen.

Combined Distal Femoral Nerve Block; Saphenous Nerve Block Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Hôpital privé Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (15)

• 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.

  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.

  PMID: 15915023 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.

  PMID: 35243362 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.

  PMID: 26375568 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.

  PMID: 32842722 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.

  PMID: 28606458 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.

  PMID: 28079176 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.

  PMID: 27007076 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.

  PMID: 19413820 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.

  PMID: 32253065 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.

  PMID: 39645191 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.

  PMID: 22357571 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.

  PMID: 30983589 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Antoine Sanchez, MD

  Hôpital privé Dijon Bourgogne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Sanchez

CONTACT

+33 3 80 40 01 14; sanchez.antoine@live.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 5, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months and ending 36 months after publication of the main results
• Access Criteria: 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.

Locations

FR (1)