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Not yet recruitingNCT06088368Updated Oct 18, 2023

Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method

An interventional study of in-plane needle guidance and out-of-plane needle guidance in Femoral Neck Fractures, Lumbosacral Plexus and Nerve Block, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The more effective use of ultrasound in regional anaesthesia techniques has made different block applications possible. Lumbar plexus block is also used for post-operative analgesia and surgical anaesthesia. Currently, in-plane ultrasound-guided LPB is widely used in short-axis imaging and Shamrock imaging.

Read the detailed description

The purpose of this use is to investigate the effectiveness of lumbar plexus block application applied with in-plane and out-of-plane methods accompanied by Shamrock imaging.

02

Conditions studied

  • Femoral Neck Fractures
  • Lumbosacral Plexus
  • Nerve Block
03

In context

Femoral Neck Fractures

207 studies on the registry are indexed under Femoral Neck Fractures; 40 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 142 interventional studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Bursa Yüksek İhtisas Education and Research Hospital is the lead sponsor of 62 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-90 years old
  • ASA (American Society of Anaesthesiologist) Score I-III risk class
  • Patients who will undergo femoral neck fracture operation.

Exclusion criteria

Exclusion Criteria:

  • Local Anaesthetic Allergy
  • With Bleeding Diathesis Disorder
  • Mental Disorders
  • Allergic to the medicines used
  • Previous Cerebrovascular Disease
  • above 30
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    in-plane needle guidance

    Ultrasound -guided lumbar plexus block

    Procedure: in-plane needle guidance

  • Active comparator
    out-of-plane needle guidance

    Ultrasound -guided lumbar plexus block

    Procedure: out-of-plane needle guidance

Interventions

  • Procedurein-plane needle guidance

    Ultrasound -guided lumbar plexus block with in-plane needle guidance using the Shamrock method

  • Procedureout-of-plane needle guidance

    Ultrasound -guided lumbar plexus block with out-of-plane needle guidance using Shamrock method

06

What researchers measure

Primary outcomes

  1. Block application time

    The stopwatch will be started by another researcher with the needle skin penetration and the stopwatch will be stopped as soon as the needle leaves the skin.

    Time frame: up to 20 minutes

Secondary outcomes

  1. Number of interventions

    intervention from the same or another site after exiting the skin

    Time frame: up to 20 minutes

  2. The number of needle guidance

    Retraction and re-advancement of the needle after skin entry without exiting the skin

    Time frame: up to 20 minutes

  3. sensory block

    Both lower limbs sensory block time after the applied block will be evaluated by pinprick and cold test (10.15., 20., 25., 30., 35. and 40 minutes).

    Time frame: up to 40 minutes

  4. motor block

    Both lower limbs Modified Bromage scale was used to evaluate motor block. Modified Bromage scale 0 No motor block 1. Raises the knee in flexion 2. Raises the ankle 3. Full block, can't move his foot

    Time frame: up to 40 minutes

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06088368
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Korgün Ökmen (Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
Oct 18, 2023
Start date
Oct 20, 2023 (estimated)
Primary completion
Jan 25, 2024 (estimated)
Completion
Feb 13, 2024 (estimated)
Last update
Oct 18, 2023

Study contacts

Korgün Ökmen, Assoc. PhD.
Contact
korgunokmen@gmail.com
+902242955000
Korgün Ökmen, Assoc. PhD.
principal investigator · Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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