Radiological Study of PENG Block Depth | NCT04337164

Studies
Radiological Study of PENG Block Depth

NCT04337164

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Dec 21, 2020Actual

Enrollment

101Actual

Phase

Not provided

Conditions

Regional Anesthesia
Computed Tomography
Anatomical Description

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

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2020Actual

Primary Completion Date

Jul 10, 2020Actual

Completion Date

Jul 10, 2020Actual

First Submitted Date

Mar 31, 2020

First Submission Date that Met QC Criteria

Apr 3, 2020

First Posted Date

Apr 7, 2020Actual

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

Dec 18, 2020

Last Update Posted Date

Dec 21, 2020Actual

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

This study evaluates the depth of anatomical landmarks required in regional anaesthesia to perform either Femoral Nerve Block or PENG Block.

Measures will be performed on abdominal and pelvic computed tomography as part of daily routine patient care.

Detailed Description

PENG Block is a new approach in regional anesthesia for hip surgery. The anatomical landmarks used to perform PENG Block are deeper than those for Femoral Nerve Block. Nevertheless, depth required for PENG Block is not yet evaluated since it may vary between patients.

Daily routine abdominal and pelvic computed tomography allow such anatomical description.

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

101Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PENG Block depth	Measure of puncture depth required to achieve a PENG Block on CT Scann images	1 hour after radiological examination

Secondary Outcomes

Measure	Description	Time Frame
Femoral Nerve Block depth	Measure of puncture depth required to achieve a Femoral Nerve Block on CT Scann images	1 hour after radiological examination
puncture angle needed	Measure of puncture angle that would be required to achieve a PENG Block depth on CT Scann images

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients who have had a CT scan including visualization of the pelvis and who have expressed no opposition

Exclusion Criteria:

pregnancy
Subject presenting a pathology likely to modify the anatomical landmarks studied: ie pelvic fracture, psoas haematoma, previous pelvic surgery or hip prosthesis or femoral bypass

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

Patients who had a CT scan in a single institution

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire		Besançon		25000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

In accordance with future institutional decisions

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided