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

Not Applicable

Active, not recruiting

• Conditions: Anesthesia; Anterior Cruciate Ligament Reconstruction
• Interventions: Procedure: adductor canal block; Procedure: iPACK block

• Registration Number: NCT05136352
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-29
• Study Start: 2021-12-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-16
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cumulative opioid consumption at 48 hours after surgery	Hours 48	Cumulative opioid consumption in the first 48 hours after anterior cruciate ligament repair surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France