An interventional study of Femoral Nerve 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 2026-11-05.
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 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:
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.
5,265 studies on the registry are indexed under Pain, Postoperative; 1,165 are open to participants now.
This study's planned enrollment of 108 is above the median of 75 across 4,496 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
Participants 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.
Procedure: iPACK Block · Procedure: Nerve to Vastus Medialis Block · Procedure: Anterior Obturator Nerve Block · Procedure: Adductor Canal Block
Participants 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.
Procedure: Femoral Nerve Block · Procedure: iPACK Block
Ultrasound-guided femoral nerve block administered as part of the standard regional anesthesia protocol for ACL reconstruction.
Ultrasound-guided infiltration between the popliteal artery and the posterior capsule of the knee (iPACK) administered as part of the regional anesthesia protocol.
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.
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.
Ultrasound-guided adductor canal block administered as part of the targeted regional anesthesia protocol for ACL reconstruction 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 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.
Time frame: Baseline (preoperatively, before regional anesthesia) and 24 hours after surgery
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).
Time frame: 6, 24, and 48 hours after surgery
Postoperative Opioid Consumption
Total opioid consumption will be recorded and converted to oral morphine equivalents (OME).
Time frame: 24 and 48 hours after surgery
Postoperative Nausea and Vomiting
The incidence of postoperative nausea and vomiting (PONV) will be recorded.
Time frame: 24 and 48 hours after surgery
Time to ambulation
Time from completion of surgery to first postoperative ambulation will be recorded.
Time frame: Day 0 (postoperative)
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.
Time frame: Day 0 and Day 1 after surgery
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.
Time frame: Day 0 and 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: 1 month after surgery
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.
Time frame: Day 0
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 1,916 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 12 months is close to that.
Counting every sponsor, half of 1,929 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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