NCT05303233

Brief Summary

The purpose of this study is to compare the analgesic efficacy of the combination of an adductor canal and selective tibial nerve blocks versus adductor canal block and IPACK after ACL reconstruction under general anaesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

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

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
Last Updated

August 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

March 21, 2022

Last Update Submit

August 5, 2025

Conditions

Keywords

Regional anesthesiaSelective tibial nerve blockIPACKAnterior cruciate ligament reconstructionMultimodal analgesiaLocal anesthetics

Outcome Measures

Primary Outcomes (1)

  • Total intravenous morphine consumption

    Consumption in mg

    1 day postoperatively

Secondary Outcomes (13)

  • Total intravenous morphine consumption

    2 hours and 2 days postoperatively

  • Resting and dynamic pain score

    2 hours, 1 day and 2 days postoperatively

  • Incidence of postoperative nausea and vomiting

    2 hours, 1 day and 2 days postoperatively

  • Range of motion

    1 day and 2 days postoperatively

  • Quadriceps strength

    1 day and 2 days postoperatively

  • +8 more secondary outcomes

Study Arms (2)

TIBIAL group

EXPERIMENTAL

All patients allocated to the TIBIAL group will receive an adductor canal block with 20ml of ropivacaine 0.75% and a selective tibial nerve block with 5 ml of ropivacaine 0.75% prior to surgery,

Procedure: Selective tibial nerve block

IPACK group

ACTIVE COMPARATOR

All patients allocated to the IPACK group will receive an adductor canal block with 20ml of ropivacaine 0.75% and an IPACK with 20ml of ropivacaine 0.2% prior to surgery.

Procedure: IPACK

Interventions

The selective tibial nerve block will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position at the popliteal crease to visualize the popliteal artery and the tibial nerve in short axis. A 21-gauge 50mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound bean from a medial to lateral direction. Once the needle tip is adjacent to the tibial nerve, 5 ml of ropivacaine 0.75% will be injected to achieve an adequate spread of local anaesthetics around the nerve.

TIBIAL group
IPACKPROCEDURE

The IPACK will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position proximal to the popliteal crease to visualize the popliteal artery in short axis. A 21-gauge 100 mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound beam, in a lateral to medial direction, between the popliteal artery and the posterior capsule, where twenty mL of ropivacaine 0.2% will be injected under ultrasound guidance. The distribution of local anaesthetics will be observed above the posterior capsule.

IPACK group

Eligibility Criteria

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

You may qualify if:

  • ASA score I-III
  • years or older
  • Scheduled for elective primary ACL reconstruction
  • Signature of consent form

You may not qualify if:

  • Refusal or inability for informed consent
  • Known allergies to ropivacaine, acetaminophen, ibuprofen, ketorolac, morphine, sufentanyl, ondansetron or dexamethason
  • Secondary surgical revision
  • Opioid treatment such as morphine, hydrocodone, hydromorphone, tramadol, methadone, fentanyl, buprenorphine or codeine
  • Bleeding diathesis
  • Neurological deficit
  • Known renal insufficiency (eGFR \<45 ml/min)
  • Known hepatic insufficiency (Child score B or C)
  • Pregnancy or lactating
  • Alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Lausanne

Lausanne, 1011, Switzerland

Location

Related Publications (7)

  • Chuaychoosakoon C, Parinyakhup W, Wiwatboworn A, Purngpiputtrakul P, Wanasitchaiwat P, Boonriong T. Comparing post-operative pain between single bundle and double bundle anterior cruciate ligament reconstruction: a retrospective study. BMC Musculoskelet Disord. 2021 Sep 3;22(1):753. doi: 10.1186/s12891-021-04635-5.

    PMID: 34479511BACKGROUND
  • Smith JH, Belk JW, Kraeutler MJ, Houck DA, Scillia AJ, McCarty EC. Adductor Canal Versus Femoral Nerve Block after Anterior Cruciate Ligament Reconstruction: A Systematic Review of Level I Randomized Controlled Trials Comparing Early Postoperative Pain, Opioid Requirements, and Quadriceps Strength. Arthroscopy. 2020 Jul;36(7):1973-1980. doi: 10.1016/j.arthro.2020.03.040. Epub 2020 Apr 18.

    PMID: 32315764BACKGROUND
  • Jansen TK, Miller BE, Arretche N, Pellegrini JE. Will the addition of a sciatic nerve block to a femoral nerve block provide better pain control following anterior cruciate ligament repair surgery? AANA J. 2009 Jun;77(3):213-8.

    PMID: 19645171BACKGROUND
  • Silverman ER, Vydyanathan A, Gritsenko K, Shaparin N, Singh N, Downie SA, Kosharskyy B. The Anatomic Relationship of the Tibial Nerve to the Common Peroneal Nerve in the Popliteal Fossa: Implications for Selective Tibial Nerve Block in Total Knee Arthroplasty. Pain Res Manag. 2017;2017:7250181. doi: 10.1155/2017/7250181. Epub 2017 Feb 2.

    PMID: 28260964BACKGROUND
  • Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.

    PMID: 31130273BACKGROUND
  • Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.

    PMID: 34039734BACKGROUND
  • van der Wal M, Lang SA, Yip RW. Transsartorial approach for saphenous nerve block. Can J Anaesth. 1993 Jun;40(6):542-6. doi: 10.1007/BF03009739.

    PMID: 8403121BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Albrecht, M.D.

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Eric Albrecht

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

May 1, 2022

Primary Completion

November 14, 2024

Study Completion

July 14, 2025

Last Updated

August 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations