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NCT07919756
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Conditions: Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 108
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Location: Clinique du Mousseau Évry
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 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.
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Source: ClinicalTrials.gov (NCT07919756). StuddyBuddy aggregates publicly available trial information.