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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2023-12-31

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.

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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.

Conditions

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Anesthesia Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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adductor canal block

loco-regional analgesia with adductor canal block (ACB) method (for anterior cruciate ligament reconstruction )

Group Type ACTIVE_COMPARATOR

adductor canal block

Intervention Type PROCEDURE

loco-regional anesthesia using adductor canal block

iPACK block

loco-regional analgesia with iPACK block (infiltration between the popliteal artery and the capsule of the posterior knee) ((for anterior cruciate ligament reconstruction )

Group Type EXPERIMENTAL

iPACK block

Intervention Type PROCEDURE

loco-regional anesthesia using infiltration between the popliteal artery and the capsule of the posterior knee

Interventions

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adductor canal block

loco-regional anesthesia using adductor canal block

Intervention Type PROCEDURE

iPACK block

loco-regional anesthesia using infiltration between the popliteal artery and the capsule of the posterior knee

Intervention Type PROCEDURE

Other Intervention Names

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ACB

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No