NCT05760963

Brief Summary

Lumbar plexus block is described as a difficult block, thus requiring experienced practitioners. Many techniques have been used to date, notably anatomical landmarks, neurostimulation, and ultrasound-guided techniques. Among ultrasound-guided techniques, the "Trident" technique was described in 2006, while the "Shamrock" technique was described in 2013. Trident consists in putting the probe sagittally next to the lumbar spine and injecting local anesthetic around the lumbar plexus inside the psoas muscle at the level of L4. It is an out-of-plane puncture. Shamrock puts the probe transversely on the iliac crest. Authors of the 2013 article said the image obtained with this technique was an image of L4. This technique allows an in-plane puncture, which is a safe technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
Last Updated

March 9, 2023

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

February 27, 2023

Last Update Submit

February 27, 2023

Conditions

Keywords

Lumbar plexusultrasound guidedTridentShamrock

Outcome Measures

Primary Outcomes (1)

  • Projection of line C on the costiform processes

    Analysis by trident techniques results.

    Day: 0

Secondary Outcomes (3)

  • Depth of lumbar plexus

    Day: 0

  • image quality

    Day: 0

  • presence of vessels

    Day: 0

Study Arms (1)

Adult with lumbar echography indication

Adult with lumbar echography indication will be included.

Other: Collection of datas

Interventions

Analysis lumbar echographies results by Trident ans Shamrock techniques. Costiform processes on T12 to L5 were spotted and noted. For Trident technique, quality of image, depth of lumbar plexus and presence of vessels were noted. Shamrock technique was performed, the projection of C line (line obtained with a probe put on the iliac crest) was noted with the invisible ink pen. Then the probe was oriented cephalically (for line \>C) and caudally (line \<C). For each lines, quality of image, depth of lumbar plexus and presence of vessels were also noted. The projections of C, \>C, \<C on the costiform processes were noted.

Adult with lumbar echography indication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult with indication of lumbar echography will be included.

You may qualify if:

  • Adult with indication of lumbar echography

You may not qualify if:

  • Antecedent of spine surgery or spinal malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

Study Officials

  • Maxime WODEY, resident

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

January 1, 2019

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

March 9, 2023

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations