NCT06088368

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2024

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 12, 2023

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

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.

    up to 20 minutes

Secondary Outcomes (4)

  • Number of interventions

    up to 20 minutes

  • The number of needle guidance

    up to 20 minutes

  • sensory block

    up to 40 minutes

  • motor block

    up to 40 minutes

Study Arms (2)

in-plane needle guidance

ACTIVE COMPARATOR

Ultrasound -guided lumbar plexus block

Procedure: in-plane needle guidance

out-of-plane needle guidance

ACTIVE COMPARATOR

Ultrasound -guided lumbar plexus block

Procedure: out-of-plane needle guidance

Interventions

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

in-plane needle guidance

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

out-of-plane needle guidance

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Local Anaesthetic Allergy
  • With Bleeding Diathesis Disorder
  • Mental Disorders
  • Allergic to the medicines used
  • Previous Cerebrovascular Disease
  • Body Mass Index above 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Korgün Ökmen, Assoc. PhD.

    Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Korgün Ökmen, Assoc. PhD.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 18, 2023

Study Start

October 20, 2023

Primary Completion

January 25, 2024

Study Completion

February 13, 2024

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations