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Pain After Total Knee ArthroplastyFEM-COMBNCT07629388

Combined Distal Femoral Nerve Block for Pain Control After Knee Replacement

A study testing Combined distal femoral nerve block, Saphenous nerve block alone and Standard perioperative care in both groups in people with Pain After Total Knee Arthroplasty and Pain Management, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Combined distal femoral nerve block, Saphenous nerve block alone and Standard perioperative care in both groups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteFrance
Study dates
26 May 2026to 25 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Hôpital privé Dijon Bourgogne

    Dijon, 21000

    Antoine SANCHEZ, Dr, +33 3 80 40 01 14, sanchez.antoine@live.fr

    Recruiting

Other trials in France

About this study

Official title: 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?
Read more

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.
Being tested
Combined distal femoral nerve block, Saphenous nerve block alone, Standard perioperative care in both groups
Keywords
total knee arthroplasty, distal femoral nerve block, saphenous nerve block, femoral triangle block, postoperative pain, opioid consumption, regional anesthesia
Medical subject headings
Agnosia, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined distal femoral nerve blockProcedure or surgery

    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.

  • Saphenous nerve block aloneProcedure or surgery

    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 groupsProcedure or surgery

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

Study groups in NCT07629388
Study groupRoleWhat they receive
Combined Distal Femoral Nerve BlockExperimentalParticipants 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.
Receives: Procedure: Combined distal femoral nerve block; Procedure: Standard perioperative care in both groups
Saphenous Nerve Block AloneActive comparatorParticipants 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.
Receives: Procedure: Saphenous nerve block alone; Procedure: Standard perioperative care in both groups

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From arrival in PACU until discharge from PACU, on postoperative day 0.

Secondary outcomes (10)
  1. 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.

    Measured: During block administration on postoperative day 0.

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

    Pain intensity measured with a 10-point visual analog scale (VAS), in which 0 indicates no pain and 10 indicates maximal pain.

    Measured: 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).

  3. 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.

    Measured: Postoperative day 0 in PACU and postoperative day 1.

  4. Time to First Standing

    Delay until first mobilization/first standing after surgery.

    Measured: Postoperative day 0.

  5. Postoperative Nausea and Vomiting

    Incidence of postoperative nausea and vomiting in post-anesthesia care unit (PACU).

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

  6. Oral Opioid Consumption on the Ward

    Total oral opioid use during hospitalization, reported as oral morphine equivalent.

    Measured: Postoperative day 1 and until hospital discharge (up to 7 days).

  7. Co-analgesic Consumption

    Use of co-analgesics including nefopam, paracetamol, opium, and ketoprofen during hospitalization.

    Measured: Postoperative day 1 and until hospital discharge (up to 7 days).

  8. Intraoperative Medication Use

    Consumption of hypotensive drugs, vasopressors, and opioids during surgery.

    Measured: Intraoperative period on postoperative day 0.

  9. Length of Hospital Stay

    Duration of hospitalization after surgery.

    Measured: At hospital discharge, up to 7 days after surgery.

  10. 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.

    Measured: At hospital discharge, up to 7 days after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start26 May 2026
  3. Primary completion25 May 2027 (estimated)
  4. Study completion25 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07629388
Sponsor's protocol ID
COS-RGDS-2025-06-051-P-SANCHEZ
Other IDs
2025-A02529-40
Acronym
FEM-COMB
Status last verified
May 2026
First submitted
27 May 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 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: 10.1016/S2665-9913(21)00371-4. eCollection 2022 Mar.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 28606458
  • 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.

    PubMed 28079176
  • 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.

    PubMed 27007076
  • 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.

    PubMed 19413820
  • 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.

    PubMed 32253065
  • 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.

    PubMed 39645191
  • 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.

    PubMed 22357571
  • 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.

    PubMed 30983589

Questions about this trial

What is this clinical trial studying?

A study testing Combined distal femoral nerve block, Saphenous nerve block alone and Standard perioperative care in both groups in people with Pain After Total Knee Arthroplasty and Pain Management, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antoine Sanchez (+33 3 80 40 01 14, sanchez.antoine@live.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Opioid Consumption in post-anesthesia care unit (PACU). (time frame: From arrival in PACU until discharge from PACU, on postoperative day 0.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07629388, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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