An interventional study of Adductor Canal Block and iPACK Block in Anterior Cruciate Ligament (ACL) Reconstruction Surgery, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Treatment
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.
The study will also assess:
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 108 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Procedure: Adductor Canal Block · Procedure: iPACK Block · Procedure: Lateral Femoral Cutaneous Nerve Block
Participants 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.
Procedure: Adductor Canal Block · Procedure: iPACK Block
Ultrasound-guided adductor canal block administered as part of the standard regional analgesia protocol for ACL reconstruction with MacIntosh-type lateral extra-articular tenodesis.
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.
Ultrasound-guided lateral femoral cutaneous nerve (LFCN) block administered in addition to the adductor canal block and iPACK block in the experimental arm.
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.
Time frame: 24 hours after surgery
Preservation of Quadriceps Function
Quadriceps function will be assessed by the ability to perform a straight leg raise (SLR) at 24 hours postoperatively.
Time frame: 24 hours after surgery
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).
Time frame: 6, 24, and 48 hours after surgery
Cumulative Postoperative Opioid Consumption
Total oral opioid consumption will be recorded and converted to morphine milligram equivalents (MME).
Time frame: Day 0, Day 1, and Day 2 after surgery
Postoperative Nausea and Vomiting
The incidence of postoperative nausea and vomiting (PONV) will be recorded during the postoperative period.
Time frame: Day 0, Day 1, and Day 2 after surgery
Time to First Postoperative Ambulation
Time from surgery to first postoperative ambulation will be recorded in hours.
Time frame: Day 1 after surgery
Patient Satisfaction With Analgesic Management
Patient satisfaction with postoperative analgesic management will be assessed using a 5-point Likert scale.
Time frame: Day 1 and Day 2 after surgery
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.
Time frame: Day 1 and 1 month after surgery
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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