Regional AnesthesiaTomo-PENGNCT04337164
Radiological Study of PENG Block Depth
An observational study of Regional Anesthesia and Computed Tomography, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anesthesia, Computed Tomography, Anatomical Description
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2020to 10 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had a CT scan in a single institution
Who may be able to join
- All adult patients who have had a CT scan including visualization of the pelvis and who have expressed no opposition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Tomodensitometric Study of the Anatomical Landmarks Depth Required to Perform Femoral Nerve Block or PENG Block. The Tomo-PENG Study.
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.
Read the 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.
- Keywords
- PENG block
What is being measured
The primary outcome is the main question the study is designed to answer.
PENG Block depth
Measure of puncture depth required to achieve a PENG Block on CT Scann images
Measured: 1 hour after radiological examination
Secondary outcomes (3)
Femoral Nerve Block depth
Measure of puncture depth required to achieve a Femoral Nerve Block on CT Scann images
Measured: 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
Measured: 1 hour after radiological examination
needle length needed
Measure of needle length that would be required to achieve a PENG Block depth on CT Scann images
Measured: 1 hour after radiological examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start8 Apr 2020
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337164
- Sponsor's protocol ID
- 2020-495
- Acronym
- Tomo-PENG
- Status last verified
- Dec 2020
- First submitted
- 31 Mar 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In accordance with future institutional decisions
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Tomodensitometric Study of the Anatomical Landmarks Depth Required to Perform Femoral Nerve Block or PENG Block. The Tomo-PENG Study.
- ClinicalTrials.gov ID
- NCT04337164
- Acronym / sponsor ID
- Tomo-PENG / 2020-495
- Keywords
- PENG block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had a CT scan in a single institution
Key inclusion criteria (1 listed)
- All adult patients who have had a CT scan including visualization of the pelvis and who have expressed no opposition
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PENG Block depth
Time frame: 1 hour after radiological examination
Measure of puncture depth required to achieve a PENG Block on CT Scann images
3 secondary outcomes
Femoral Nerve Block depth
Time frame: 1 hour after radiological examination
puncture angle needed
Time frame: 1 hour after radiological examination
needle length needed
Time frame: 1 hour after radiological examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: Undecided. In accordance with future institutional decisions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia and Computed Tomography, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PENG Block depth (time frame: 1 hour after radiological examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.