NCT05136352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

October 20, 2021

Last Update Submit

March 4, 2026

Conditions

AnesthesiaAnterior Cruciate Ligament Reconstruction

Keywords

loco-regional anesthesiaanterior cruciate ligament reconstructionmultimodal analgesiamotor sparingiPACK block

Outcome Measures

Primary Outcomes (1)

  • Cumulative opioid consumption at 48 hours after surgery

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

    Hours 48

Secondary Outcomes (6)

  • Cumulative opioid consumption at 2 hours after surgery

    Hours 2

  • Cumulative opioid consumption at 24 hours after surgery

    Hours 24

  • Cumulative opioid consumption at 3 months

    month 3

  • Maximum pain score in the recovery room

    hours 2

  • Maximum pain score at 24 hours after surgery

    hours 24

  • +1 more secondary outcomes

Study Arms (2)

adductor canal block

ACTIVE COMPARATOR

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

Procedure: adductor canal block

iPACK block

EXPERIMENTAL

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

Procedure: iPACK block

Interventions

iPACK blockPROCEDURE

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

iPACK block
adductor canal blockPROCEDURE

loco-regional anesthesia using adductor canal block

Also known as: ACB
adductor canal block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • ACL repair surgery under general anesthesia
  • Person affiliated or beneficiary of a social security plan
  • Free, informed and written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

Location

Related Publications (1)

  • Ferre F, Boussaguet L, Vari N, Pillard F, Bosch L, Ferrier A, Ba C, Tissot B, Menut R, Kurrek M, Labaste F, Cavaignac E, Minville V. Comparison of femoral triangle plus iPACK blocks with femoral triangle block alone for anterior cruciate ligament reconstruction: a randomized controlled clinical trial on postoperative pain and knee function. Reg Anesth Pain Med. 2025 Mar 7:rapm-2024-106108. doi: 10.1136/rapm-2024-106108. Online ahead of print.

    PMID: 40055004RESULT

Study Officials

  • Fabrice FERRE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 29, 2021

Study Start

December 13, 2021

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

FR(1)