Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery (Liga-PACK)

Toulouse University Hospital

Status: Active, not recruiting

Conditions: Anterior Cruciate Ligament Reconstruction; Anesthesia

Treatments: Procedure: iPACK block; Procedure: adductor canal block

Study type: Interventional

Funder types: Other

Identifiers

NCT05136352

RC31/21/0167

2021-A01226-35 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

adductor canal block

Active Comparator group

Description:

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

Treatment:

Procedure: adductor canal block

iPACK block

Experimental group

Description:

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

Treatment:

Procedure: iPACK block