Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery

Study Overview
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Brief Summary
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This randomised clinical trial evaluates the analgesia provided by an iPack block associated with an adductor canal block in patients who undergo anterior cruciate ligament reconstruction surgery, compared to an adductor canal block alone. The objective is to prove the superiority of this locoregional anesthesia in terms of analgesia and functional rehabilitation.

Detailed Description
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The ideal loco-regional anesthesia for anterior cruciate ligament reconstruction ensuring a satisfying analgesia without compromising an early rehabilitation is still undetermined. Femoral nerve block has been incriminated in a delayed postoperative mobilization whereas the adductor canal block gives an equivalent analgesia for a better preservation of the quadricipital muscular strength. The iPACK block (infiltration between the popliteal artery and the capsule of the posterior knee) is a recently described technique. Few studies have assessed the iPACK block in ACL reconstruction, and none were randomized. This randomized single blind clinical trial compares two groups of 45 patients who undergo ACL reconstruction surgery under general anaesthetic : one receives an iPACK block associated with an adductor canal block, and the other only has an adductor canal block. Pain scores and opioid consumption are collected after surgery in the recovery room, then by telephone interview at 24 and 48 hours post-surgery. Functional rehabilitation is evaluated by scales (KOOS, LYSHOLM and iKDC) at 3, 6 and 9 months after surgery. Adverse effects, due to anesthesia or opioids, are collected from 30 min after loco-regional anesthesia until the second phone call at 48h post-surgery.

Official Title
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Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery, the LIGA-PACK Study

Conditions
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Anesthesia, Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Procedure: adductor canal block
* Procedure: iPACK block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years ACL repair surgery under general anesthesia Person affiliated or beneficiary of a social security plan Free, informed and written consent Exclusion Criteria: Age < 18 years Contraindication to ALR (allergy to local anesthetics, local infection of the puncture site, coagulopathy) Pre-existing opiate dependence Contraindication to non-steroidal anti-inflammatory drugs Pregnant or potentially pregnant women Patients under the protection of adults (guardianship, curatorship or safeguard of justice) Patients whose cognitive state does not allow evaluation by the scales used

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: adductor canal block<br>loco-regional analgesia with adductor canal block (ACB) method (for anterior cruciate ligament reconstruction ) | Procedure: adductor canal block<br>* loco-regional anesthesia using adductor canal block<br>* Other names: ACB;|
| Experimental: iPACK block<br>loco-regional analgesia with iPACK block (infiltration between the popliteal artery and the capsule of the posterior knee) ((for anterior cruciate ligament reconstruction ) | Procedure: iPACK block<br>* loco-regional anesthesia using infiltration between the popliteal artery and the capsule of the posterior knee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative opioid consumption at 48 hours after surgery | Cumulative opioid consumption in the first 48 hours after anterior cruciate ligament repair surgery | Hours 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative opioid consumption at 2 hours after surgery | Cumulative opioid consumption in the recovery room after anterior cruciate ligament repair surgery | Hours 2 | 
| Cumulative opioid consumption at 24 hours after surgery | Cumulative opioid consumption in the first 24 hours after anterior cruciate ligament repair surgery | Hours 24 | 
| Cumulative opioid consumption at 3 months | total opioid consumption at 3 months after anterior cruciate ligament repair surgery | month 3 | 
| Maximum pain score in the recovery room | Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score) | hours 2 | 
| Maximum pain score at 24 hours after surgery | Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score) | hours 24 | 
| Maximum pain score at 48 hours after surgery | Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score) | hours 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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loco-regional anesthesia, anterior cruciate ligament reconstruction, multimodal analgesia, motor sparing, iPACK block