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NCT Number: NCT05136352

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adductor canal block

Procedure

loco-regional anesthesia using adductor canal block

Other names: ACB

IPACK block

Procedure

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

Primary outcomes

  1. Cumulative opioid consumption at 48 hours after surgery

    Time frame: Hours 48

    Cumulative opioid consumption in the first 48 hours after anterior cruciate ligament repair surgery

Secondary outcomes

  1. Cumulative opioid consumption at 2 hours after surgery

    Time frame: Hours 2

    Cumulative opioid consumption in the recovery room after anterior cruciate ligament repair surgery

  2. Cumulative opioid consumption at 24 hours after surgery

    Time frame: Hours 24

    Cumulative opioid consumption in the first 24 hours after anterior cruciate ligament repair surgery

  3. Cumulative opioid consumption at 3 months

    Time frame: month 3

    total opioid consumption at 3 months after anterior cruciate ligament repair surgery

  4. Maximum pain score in the recovery room

    Time frame: hours 2

    Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score)

  5. Maximum pain score at 24 hours after surgery

    Time frame: hours 24

    Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score)

  6. Maximum pain score at 48 hours after surgery

    Time frame: hours 48

    Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: Liga-PACK

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 29, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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