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CompletedNCT04346758Updated Dec 8, 2020

Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.

An interventional study of lumbar plexus block in Postoperative Pain, sponsored by Attikon Hospital. Completed at 1 site in Greece. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2020-12-08.

Sponsored by Attikon Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Study summary

A revised ultrasound-guided approach to the lumbar plexus is investigated as for efficacy and safety in elderly trauma patients undergoing operations of the lower extremeties.

Read the detailed description

A modified ultrasound-guided Shamrock approach combined to nerve stimulation of the lumbar plexus is going to be investigated, in elderly trauma patients undergoing procedures of the lower extremities. The technique is going to be assessed as for its safety and its accuracy in localization of the plexus, by multiple measurements of the imaging time and needling time, In addition, efficacy and complications will be recorded and assessed during the immediate postoperative period.

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 48 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Attikon Hospital is the lead sponsor of 83 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients undergoing orthopedic trauma operations of the lower extremeties
  • Age >70 years old

Exclusion criteria

Exclusion Criteria:

  • Preexisting neuropathy of Lumbar plexus
  • Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
  • Allergy to local anaesthetics
  • Prior surgery at the lumbar region
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Other
    Modified Shamrock approach

    Patients undergoing orthopedic procedures of the lower extremeties are going to be studied. A modified Shamrock approach of the lumbar plexus is going to be used for postoperative analgesia, using an ultrasound-guided technique combined to a nerve stimulatior. The technique is going to be assessed as for accuracy, and safety.

    Procedure: lumbar plexus block

Interventions

  • Procedurelumbar plexus block

    Patients undergoing orthopedic procedures of the lower extremeties are going to be studied. A modified Shamrock approach of the lumbar plexus is going to be used for postoperative analgesia, using an ultrasound-guided technique combined to a nerve stimulatior. The technique is going to be assessed as for accuracy, and safety.

06

What researchers measure

Primary outcomes

  1. Time required to localize the lumbar plexus

    The time (in secondes) required of this modified Shamrock method to localize the lumbar plexus in the interpsoas compartment in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. Imaging time will be calculated (time to obtain appropriate imaging of the plexus) as well as needling time (time to obtain appropriate needle placement on the plexus)

    Time frame: 10 minutes (from the begining of imaging procedure) (time in seconds to localize the plexus)

  2. Complications from lumbar plexus blockade

    Safety of the modified Shamrock method of lumbar plexus blockade in elderly-trauma patients undergoing orthopedic procedures of the lower extremeties. All possible complications will be recorded (i.e. neurological complications, numbness, mobility disorder, haemmorhage, haematoma, e.t.c.)

    Time frame: 1 month

Secondary outcomes

  1. Postoperative pain

    Postoperative pain relief 4 hours after completion of the block (visual analogue scale 0-10). A VAS score \<4 is considered adequate.

    Time frame: 4 hours (visual analogue scale 0-10 at 4 hours postoperatively)

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Study locations

1 site
  • Attikon Hospital
    Athens, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04346758
Lead sponsor
Attikon Hospital
Collaborators
University of Athens
Responsible party
THEODOSIOS SARANTEAS (Associate Professor of Anesthesiology, Attikon Hospital) — Principal investigator
First posted
Apr 15, 2020
Start date
Feb 15, 2020
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020
Last update
Dec 8, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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