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Anterior Cruciate Ligament (ACL) Reconstruction SurgeryRECUP- NCLCNCT07925099

Lateral Femoral Cutaneous Nerve Block (LFCN) in ACL Reconstruction With MacFL-type Lateral Tenodesis

A study testing Adductor Canal Block, iPACK Block and Lateral Femoral Cutaneous Nerve Block in people with Anterior Cruciate Ligament (ACL) Reconstruction Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this randomized clinical trial is to evaluate whether adding an ultrasound-guided lateral femoral cutaneous nerve (LFCN) block to a standard regional analgesia protocol improves postoperative recovery in patients undergoing anterior cruciate ligament (ACL) reconstruction combined with MacIntosh-type… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Adductor Canal Block, iPACK Block and Lateral Femoral Cutaneous Nerve Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
2 sitesFrance
Study dates
1 Nov 2026to 1 Nov 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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients aged 18 to 60 years;
  • Presenting a primary anterior cruciate ligament (ACL) tear;
  • Scheduled for ACL reconstruction associated with MacIntosh-type lateral extra-articular tenodesis (or equivalent technical variant using an iliotibial band 'ITB' graft);
  • Surgery to be performed under general anesthesia;
  • Planned management in outpatient surgery or short-stay hospitalization after the operation;
  • Understanding the validated French version of the QoR-15 questionnaire;
  • Having given their informed consent to participate in the study;
  • Patients affiliated with or benefiting from a social security scheme.

Who cannot join

  • Patients having allergy to local anesthetics or a contraindication to peripheral nerve blocks;
  • Patients having neuropathy of the lower limbs;
  • Patients having coagulation disorders or on major anticoagulation;
  • Patients suffering from chronic pain that requires more than 30 mg morphine-equivalents per day;
  • Patients undergoing revision ACL reconstruction;
  • Patients with pre-existing hypoesthesia of the lateral thigh (e.g. known meralgia paresthetica);
Show all 9Show fewer
  • Patients unable to complete the questionnaires or expressing refusal to participate;
  • Pregnant women, women of childbearing age without effective contraception), or women breastfeeding;
  • Protected adults under guardianship, curatorship or other legal protection, deprived of liberty or under guardianship or curatorship, or unable to give consent.

Trial locations and contacts

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

Yoann ELMALEH contact

+33 07 81 33 04 31

yoann.d.elmaleh@gmail.com

France2 sites

  • Clinique du Mousseau

    Évry

    Karim Guessous, +33 6 51 99 54 38, k.guessous@quincyanesthesie.com

  • Hôpital Privé Claude Galien

    Quincy-sous-Sénart

    Yoan Elmaleh, +33 7 81 33 04 31, yoann.d.elmaleh@gmail.com

Other trials in France

About this study

The goal of this randomized clinical trial is to evaluate whether adding an ultrasound-guided lateral femoral cutaneous nerve (LFCN) block to a standard regional analgesia protocol improves postoperative recovery in patients undergoing anterior cruciate ligament (ACL) reconstruction combined with MacIntosh-type lateral extra-articular tenodesis.

The main question the study aims to answer is whether adding an LFCN block to an adductor canal block (ACB) and an iPACK block improves the quality of postoperative recovery, as measured by the Quality of Recovery-15 (QoR-15) score at 24 hours after surgery.

Read more

The study will also assess:

  • Preservation of quadriceps function, assessed by the ability to perform a straight leg raise (SLR).
  • Postoperative pain at the lateral thigh graft harvest site and knee, at rest and during mobilization.
  • Cumulative oral opioid consumption during the first 48 hours after surgery.
  • Incidence of postoperative nausea and vomiting (PONV).
  • Time to first postoperative ambulation.
  • Patient satisfaction with analgesic management.

Adverse events and complications related to regional anesthesia, including sensory disturbances, hematoma, infection, and signs of local anesthetic systemic toxicity.

Participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. All participants will undergo ACL reconstruction combined with MacIntosh-type lateral extra-articular tenodesis and will receive an ACB and an iPACK block. Participants in the experimental group will additionally receive an ultrasound-guided LFCN block.

Postoperative assessments will include QoR-15, pain scores, opioid consumption, PONV, quadriceps function, ambulation, patient satisfaction, and safety assessments during the first 48 hours after surgery and at 1 month. The primary outcome will compare the QoR-15 score at 24 hours between the two groups, with an 8-point difference considered clinically meaningful.

Being tested
Adductor Canal Block, iPACK Block, Lateral Femoral Cutaneous Nerve Block
Keywords
ACL reconstruction, LFCN block, MacIntosh tenodesis, QoR-15, Postoperative pain, iPACK block, Adductor canal block, lateral femoral cutaneous nerve block, lateral extra-articular tenodesis
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Adductor Canal BlockProcedure or surgery

    Ultrasound-guided adductor canal block administered as part of the standard regional analgesia protocol for ACL reconstruction with MacIntosh-type lateral extra-articular tenodesis.

  • iPACK BlockProcedure or surgery

    Ultrasound-guided iPACK block (infiltration between the popliteal artery and the posterior capsule of the knee) administered as part of the standard regional analgesia protocol.

  • Lateral Femoral Cutaneous Nerve BlockProcedure or surgery

    Ultrasound-guided lateral femoral cutaneous nerve (LFCN) block administered in addition to the adductor canal block and iPACK block in the experimental arm.

Study groups in NCT07925099
Study groupRoleWhat they receive
ACB + iPACK + LFCN BlockExperimentalParticipants will undergo anterior cruciate ligament reconstruction combined with MacIntosh-type lateral extra-articular tenodesis. They will receive an adductor canal block (ACB) and an iPACK block as the standard regional analgesia protocol, with the addition of an ultrasound-guided lateral femoral cutaneous nerve (LFCN) block.
Receives: Procedure: Adductor Canal Block; Procedure: iPACK Block; Procedure: Lateral Femoral Cutaneous Nerve Block
ACB + iPACKActive comparatorParticipants will undergo anterior cruciate ligament reconstruction combined with MacIntosh-type lateral extra-articular tenodesis. They will receive an adductor canal block (ACB) and an iPACK block without an additional lateral femoral cutaneous nerve (LFCN) block.
Receives: Procedure: Adductor Canal Block; Procedure: iPACK Block

What is being measured

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

  1. Quality of Recovery (QoR-15) Score

    The quality of postoperative recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 score ranges from 0 to 150, with higher scores indicating better quality of recovery. The score will be assessed preoperatively before administration of regional anesthesia and again 24 hours after surgery. The primary analysis will compare the QoR-15 score at 24 hours between the experimental and active comparator groups. An 8-point difference between groups is considered the minimal clinically important difference.

    Measured: 24 hours after surgery

Secondary outcomes (7)

  1. Preservation of Quadriceps Function

    Quadriceps function will be assessed by the ability to perform a straight leg raise (SLR) at 24 hours postoperatively.

    Measured: 24 hours after surgery

  2. Postoperative Lateral Thigh and Knee Pain

    Pain intensity at the lateral thigh graft harvest site and knee will be assessed at rest and during mobilization using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable).

    Measured: 6, 24, and 48 hours after surgery

  3. Cumulative Postoperative Opioid Consumption

    Total oral opioid consumption will be recorded and converted to morphine milligram equivalents (MME).

    Measured: Day 0, Day 1, and Day 2 after surgery

  4. Postoperative Nausea and Vomiting

    The incidence of postoperative nausea and vomiting (PONV) will be recorded during the postoperative period.

    Measured: Day 0, Day 1, and Day 2 after surgery

  5. Time to First Postoperative Ambulation

    Time from surgery to first postoperative ambulation will be recorded in hours.

    Measured: Day 1 after surgery

  6. Patient Satisfaction With Analgesic Management

    Patient satisfaction with postoperative analgesic management will be assessed using a 5-point Likert scale.

    Measured: Day 1 and Day 2 after surgery

  7. Safety and Adverse Events Related to Regional Anesthesia

    Adverse events and complications potentially related to regional anesthesia will be recorded, including hypoesthesia or paresthesia of the lateral thigh, abnormal sensory disturbances, hematoma at the LFCN block site, infection, and signs of local anesthetic systemic toxicity.

    Measured: Day 1 and 1 month 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 posted9 Nov 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 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
Single blind
Who is masked
Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07925099
Sponsor's protocol ID
COS-RGDS-2025-12-027-P-ELMALEH
Other IDs
2026-A01042-49
Acronym
RECUP- NCLC
Status last verified
Sep 2026
First submitted
3 Nov 2026
Last updated
9 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Leger M, Campfort M, Cayla C, Parot-Schinkel E, Lasocki S, Rineau E. Validation of an alternative French version of the Quality of Recovery-15 Score: the FQoR-15. Br J Anaesth. 2020 Oct;125(4):e345-e347. doi: 10.1016/j.bja.2020.05.052. Epub 2020 Jul 9. No abstract available.

    PubMed 32654751

  • Le Bescond V, Petit-Phan J, Campfort M, Nicolleau C, Conte M, Bouhours G, Rony L, Lasocki S, Leger M. Validation of the postoperative Quality of Recovery-15 questionnaire after emergency surgery and association with quality of life at three months. Can J Anaesth. 2024 May;71(5):590-599. doi: 10.1007/s12630-024-02722-4. Epub 2024 Mar 19.

    PubMed 38504036

  • Myles PS, Myles DB, Galagher W, Chew C, MacDonald N, Dennis A. Minimal Clinically Important Difference for Three Quality of Recovery Scales. Anesthesiology. 2016 Jul;125(1):39-45. doi: 10.1097/ALN.0000000000001158.

    PubMed 27159009

  • Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.

    PubMed 32303379

  • Nakase J, Shimozaki K, Asai K, Yoshimizu R, Kimura M, Tsuchiya H. Usefulness of lateral femoral cutaneous nerve block in combination with femoral nerve block for anterior cruciate ligament reconstruction: a prospective trial. Arch Orthop Trauma Surg. 2021 Mar;141(3):455-460. doi: 10.1007/s00402-020-03724-9. Epub 2021 Jan 2.

    PubMed 33386977

  • Garg DR, Li D, Bordoni B. Anatomy, Bony Pelvis and Lower Limb: Lateral Femoral Cutaneous Nerve. 2026 Feb 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532301/

    PubMed 30335334

  • Wascher DC, Lording TD, Neyret P. Extra-articular procedures for the ACL-deficient knee: a state of the art review. Journal of ISAKOS. mai 2016;1(3):174-82. doi:10.1136/jisakos-2016-000053

  • Uddin I, Chazapis M. Obturator nerve block [Internet]. World Federation of Societies of Anaesthesiologists; juin 2024 [cité 4 févr 2026]. Disponible https://resources.wfsahq.org/atotw/obturator-nerve-block/ doi:10.28923/atotw.525

Questions about this trial

What is this clinical trial studying?

A study testing Adductor Canal Block, iPACK Block and Lateral Femoral Cutaneous Nerve Block in people with Anterior Cruciate Ligament (ACL) Reconstruction Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites 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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Yoann ELMALEH (+33 07 81 33 04 31, yoann.d.elmaleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery (QoR-15) Score (time frame: 24 hours after surgery). 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 NCT07925099, which also lists 8 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 9 Nov 2026.

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