Evaluation by Ultrasound Imaging of Local Anesthetic Spre... | NCT06245460

Studies
Evaluation by Ultrasound Imaging of Local Anesthetic Spread to the Popliteal Fossa During an Adductor Canal Block

NCT06245460

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Last Update Posted

Nov 24, 2025Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Knee Injuries

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2023-A01774-41	Registry Identifier	IDRCB

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal investigator want to stop the study then begining another new one

Expanded Access Info

Start Date

Mar 5, 2024Actual

Primary Completion Date

Apr 8, 2025Actual

Completion Date

Apr 8, 2025Actual

First Submitted Date

Jan 30, 2024

First Submission Date that Met QC Criteria

Jan 30, 2024

First Posted Date

Feb 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2025

Last Update Posted Date

Nov 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Adductor canal block is an effective analgesic technique for major knee surgery. However, the saphenous nerve block is not sufficient to explain this block's efficiency. It has been shown that adductor canal block can spread to the tibial and fibular nerves through the adductor hiatus. However this diffusion's frequency has never been measured. The main objective of this study is to assess the frequency of the spread of the adductor canal block to the fibular and tibial nerves assessed by ultrasound observation at the popliteal fossa.

Detailed Description

Adductor canal block is an effective analgesic technique for major knee surgery. The PROSPECT group recommends this block in first intention for locoregional anesthesia in total knee arthroplasty. It has been shown to not be inferior to femoral nerve block in this indication.

The adductor canal block targets the saphenous nerve and, through its spread in the adductor canal, the posterior branch of obturator nerve and the vastus medialis nerve. However these nerves can't fully explain this block's efficiency.

It has been shown that local anesthetic can spread in the adductor canal to the tibial and fibular nerves through the adductor hiatus. However, this spread is inconstant, and no study has evaluated the frequency of this spread yet.

The main objective of this study is to assess the diffusion's frequency of adductor canal block to fibular and tibial nerves through ultrasound observation at the popliteal fossa.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of local anesthetic's spread	The primary outcome is the frequency of local anesthetic's spread to tibial and fibular nerve during an adductor canal block, assessed by ultrasound imaging at the popliteal fossa level. The ultrasound images will be recorded and then assessed by two independent anesthesiologists.	at baseline

Secondary Outcomes

Measure	Description	Time Frame
Frequency of altered sensibility	Frequency of altered sensibility and motricity in fibular and tibial nerves territories assessed at one and four hours after the adductor canal block has been performed.	at one and four hours
Correlation between local anesthetic spread and clinical alteration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled for elective knee surgery under general anesthesia
in center of Ambroise Paré hospital
receiving an adductor canal block

Exclusion Criteria:

patients cognitively impaired
patients suffering from peripheral neuropathy at the lower limb
patients receiving an IPACK block or surgical knee infiltration to complete the adductor canal block analgesia
patients who refused to take part in this study
pregnant or breastfeeding patients
patients under guardianship
imprisoned patients
patients without any medical insurance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will be all the consecutive patients scheduled for elective knee surgery under general anesthesia in our center and receiving an adductor canal block.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Romuald Henry, MD	Department of anesthesia, Ambroise Paré Hospital - APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of anesthesia, Ambroise Paré Hospital - APHP		Boulogne-Billancourt		92100	France

Condition Browse Module

MeSH Terms

ID	Term
D007718	Knee Injuries
D000377	Agnosia
D010146	Pain

Ancestor Terms

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations

Browse Leaves

Not provided

Browse Branches

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