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Anterior Cruciate Ligament (ACL) Reconstruction SurgeryRECUP-NVMNCT07919756

Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft

A study testing Femoral Nerve Block, iPACK Block and Nerve to Vastus Medialis 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 a targeted regional anesthesia strategy combining an adductor canal block, a nerve to the vastus medialis (NVM) block, an anterior obturator nerve branch block, and an iPACK block improves postoperative recovery in patients undergoing anterior cruciate… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Femoral Nerve Block, iPACK Block and Nerve to Vastus Medialis Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
2 sitesFrance
Study dates
15 Nov 2026to 15 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.
  • Patients with a primary anterior cruciate ligament (ACL) injury.
  • Patients scheduled for ACL reconstruction using a DIDT graft under general anesthesia.
  • Patients managed as ambulatory surgery or short stay.
  • Patients who understand the validated French version of the QoR-15 questionnaire.
  • Patients who have given written informed consent to participate in the study.
  • Patients affiliated with or beneficiaries of a social security system.

Who cannot join

  • Patients with allergy to local anesthetics or a contraindication to peripheral nerve blocks.
  • Patients with lower-limb neuropathy.
  • Patients with coagulation disorders or on major anticoagulation.
  • Patients with chronic pain requiring more than 30 mg morphine-equivalents per day.
  • Patients undergoing revision ACL reconstruction or a major combined surgical procedure.
  • Pregnant women.
Show all 9Show fewer
  • Patients unable to complete the questionnaires or who refuse to participate.
  • Pregnant women or women who may be pregnant (of childbearing potential without effective contraception) or who are breastfeeding.
  • Protected adults: patients under guardianship, curatorship or other legal protection, deprived of liberty, or unable to provide informed 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 a targeted regional anesthesia strategy combining an adductor canal block, a nerve to the vastus medialis (NVM) block, an anterior obturator nerve branch block, and an iPACK block improves postoperative recovery in patients undergoing anterior cruciate ligament (ACL) reconstruction using a hamstring tendon (semitendinosus and gracilis; DIDT) graft, compared with the standard analgesic protocol used in participating centres, consisting of a femoral nerve block combined with an iPACK block.

The main question the study aims to answer is whether this targeted combination of nerve blocks, compared with the standard femoral nerve block plus iPACK regimen, 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 hypothesis is that the targeted adductor canal + NVM + anterior obturator branch + iPACK strategy will significantly improve postoperative recovery quality at 24 hours compared with the standard femoral nerve block + iPACK protocol, with an expected improvement of at least 8 points on the QoR-15 score. This 8-point difference represents the minimal clinically important difference (MCID) for this questionnaire (Léger et al., 2020). The QoR-15 is a validated global recovery assessment tool, available in French, and sensitive to variations in recovery quality in outpatient orthopedic surgery (Nakase et al., 2021). An improvement of at least 8 points at 24 hours would therefore indicate a clinically meaningful benefit from the patient's perspective.

The study will also assess:

  • Postoperative pain at rest and during mobilization.
  • Opioid consumption during the first 48 hours after surgery.
  • Incidence of postoperative nausea and vomiting.
  • Time to first ambulation.
  • Postoperative thigh edema.
  • Neuromuscular recovery of the thigh.
  • Patient satisfaction with analgesic management.
  • Adverse events related to regional anesthesia.

Participants will be randomly assigned to one of two treatment groups. All participants will undergo ACL reconstruction with a DIDT graft. Participants in the comparator group will receive a femoral nerve block combined with an iPACK block. Participants in the intervention group will receive a targeted regional anesthesia strategy combining an adductor canal block, a nerve to the vastus medialis (NVM) block, an anterior branch of the obturator nerve block, and an iPACK block.

Postoperative assessments will include pain scores, QoR-15 questionnaires, opioid consumption, nausea and vomiting, thigh measurements, and neuromuscular function assessments during the first 48 hours after surgery. Patient satisfaction and safety outcomes will also be assessed during follow-up.

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
Femoral Nerve Block, iPACK Block, Nerve to Vastus Medialis Block, Anterior Obturator Nerve Block, Adductor Canal Block
Keywords
ACL reconstruction, DIDT graft, QoR-15, Postoperative pain, Vastus medialis nerve block, iPACK block, Femoral nerve block, Adductor canal block
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Femoral Nerve BlockProcedure or surgery

    Ultrasound-guided femoral nerve block administered as part of the standard regional anesthesia protocol for ACL reconstruction.

  • iPACK BlockProcedure or surgery

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

  • Nerve to Vastus Medialis BlockProcedure or surgery

    Ultrasound-guided nerve block targeting the nerve to the vastus medialis (NVM), administered in addition to theadductor canal and iPACK blocks in the experimental arm.

  • Anterior Obturator Nerve BlockProcedure or surgery

    Ultrasound-guided block of the anterior branch of the obturator nerve, administered in addition to the adductor canal and iPACK blocks in the experimental arm.

  • Adductor Canal BlockProcedure or surgery

    Ultrasound-guided adductor canal block administered as part of the targeted regional anesthesia protocol for ACL reconstruction in the experimental arm.

Study groups in NCT07919756
Study groupRoleWhat they receive
Adductor Canal + iPACK + NVM and Anterior Obturator Nerve BlocksExperimentalParticipants will undergo anterior cruciate ligament reconstruction using a semitendinosus and gracilis (DIDT) graft. They will receive a targeted regional anesthesia protocol consisting of an adductor canal block, a nerve to the vastus medialis (NVM) block, an iPACK block, and a block of the anterior branch of the obturator nerve.
Receives: Procedure: iPACK Block; Procedure: Nerve to Vastus Medialis Block; Procedure: Anterior Obturator Nerve Block; Procedure: Adductor Canal Block
Femoral + iPACK Nerve BlocksActive comparatorParticipants will undergo anterior cruciate ligament reconstruction using a semitendinosus and gracilis (DIDT) graft. They will receive the standard regional anesthesia protocol consisting of a femoral nerve block and an iPACK block, without additional nerve blocks of the nerve to the vastus medialis (NVM) or anterior branch of the obturator nerve.
Receives: Procedure: Femoral Nerve 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 primary analysis will compare the change in QoR-15 score from baseline to 24 hours postoperatively between the experimental and active comparator groups. An 8-point difference between groups is considered the minimal clinically important difference.

    Measured: Baseline (preoperatively, before regional anesthesia) and 24 hours after surgery

Secondary outcomes (8)

  1. Postoperative Pain

    Pain intensity will be assessed using the Numeric Rating Scale (NRS), both at rest and during mobilization. The NRS ranges from 0 (no pain) to 10 (worst pain imaginable).

    Measured: 6, 24, and 48 hours after surgery

  2. Postoperative Opioid Consumption

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

    Measured: 24 and 48 hours after surgery

  3. Postoperative Nausea and Vomiting

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

    Measured: 24 and 48 hours after surgery

  4. Time to ambulation

    Time from completion of surgery to first postoperative ambulation will be recorded.

    Measured: Day 0 (postoperative)

  5. Postoperative Thigh Edema

    Postoperative changes in thigh circumference will be measured at three standardized locations: 15 cm above the superior pole of the patella, at the level of the patellar apex, and 10 cm below the patellar apex.

    Measured: Day 0 and Day 1 after surgery

  6. Postoperative Neuromuscular Recovery of the Thigh

    Neuromuscular recovery will be assessed using the Medical Research Council (MRC) scale, ranging from 0 (no muscle contraction) to 5 (normal muscle strength), across four motor tests: isometric heel press into the mattress, flattening of the popliteal fossa against the mattress, sliding knee flexion/extension, and straight-leg raise at 30 degrees.

    Measured: Day 0 and Day 1 after surgery

  7. Patient Satisfaction With Analgesic Management

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

    Measured: 1 month after surgery

  8. Adverse Events Related to Regional Anesthesia

    Adverse events related to locoregional anesthesia will be recorded, including signs of local anesthetic systemic toxicity (LAST) and persistent paresthesia.

    Measured: Day 0

Timeline

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

  1. First posted5 Nov 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion15 Nov 2027 (estimated)
  4. Study completion15 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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07919756
Sponsor's protocol ID
COS-RGDS-2025-12-028-P-ELMALEH
Other IDs
2026-A01040-51
Acronym
RECUP-NVM
Status last verified
Sep 2026
First submitted
30 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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

  • 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

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

  • Savalli L, Hernandez-Sendin MI, Puig PL, Trouve P. [Pain after anterior cruciate ligament reconstruction: detail and treatment]. Ann Readapt Med Phys. 2004 Aug;47(6):299-308. doi: 10.1016/j.annrmp.2004.05.005. French.

    PubMed 15297120

  • 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

  • Kim KY, Huh YG, Ma SH, Yoon JH, Jeong KY, Park DY, Yoon SH. Efficacy of Adductor Canal Block on Medial Knee Pain in Patients with Knee Osteoarthritis: A Randomized Single-Blind Placebo-Controlled Study. Int J Environ Res Public Health. 2022 Nov 21;19(22):15419. doi: 10.3390/ijerph192215419.

    PubMed 36430138

Questions about this trial

What is this clinical trial studying?

A study testing Femoral Nerve Block, iPACK Block and Nerve to Vastus Medialis 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 7 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 5 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: Baseline (preoperatively, before regional anesthesia) and 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 NCT07919756, 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 5 Nov 2026.

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