Clinical trial NCT05136352: Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery
Official title: Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery, the LIGA-PACK Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anesthesia
Anterior Cruciate Ligament Reconstruction
Keywords: loco-regional anesthesia
anterior cruciate ligament reconstruction
multimodal analgesia
motor sparing
iPACK block
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative opioid consumption at 48 hours after surgery
timeFrame: Hours 48
Secondary outcomes:
measure: Cumulative opioid consumption at 2 hours after surgery
timeFrame: Hours 2
measure: Cumulative opioid consumption at 24 hours after surgery
timeFrame: Hours 24
measure: Cumulative opioid consumption at 3 months
timeFrame: month 3
measure: Maximum pain score in the recovery room
timeFrame: hours 2
measure: Maximum pain score at 24 hours after surgery
timeFrame: hours 24
measure: Maximum pain score at 48 hours after surgery
timeFrame: hours 48
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Fabrice FERRE, MD
role: PRINCIPAL_INVESTIGATOR
References: