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Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method

Primary Purpose

Femoral Neck Fractures, Lumbosacral Plexus, Nerve Block

Status

Not yet recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

in-plane needle guidance

out-of-plane needle guidance

About this trial

This is an interventional treatment trial for Femoral Neck Fractures

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

in-plane needle guidance

out-of-plane needle guidance

Arm Description

Ultrasound -guided lumbar plexus block

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of interventions

intervention from the same or another site after exiting the skin

The number of needle guidance

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

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).

motor block

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

Full Information

NCT ID

NCT06088368

First Posted

October 12, 2023

Last Updated

October 17, 2023

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT06088368

Brief Title

Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method

Official Title

Investigation of the Efficacy of Different Types of Lumbar Plexus Block Applied With Ultrasound-guided Shamrock Method

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 20, 2023 (Anticipated)

Primary Completion Date

January 25, 2024 (Anticipated)

Study Completion Date

February 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoral Neck Fractures, Lumbosacral Plexus, Nerve Block

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

in-plane needle guidance

Arm Type

Active Comparator

Arm Description

Ultrasound -guided lumbar plexus block

Arm Title

out-of-plane needle guidance

Arm Type

Active Comparator

Arm Description

Ultrasound -guided lumbar plexus block

Intervention Type

Procedure

Intervention Name(s)

in-plane needle guidance

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

out-of-plane needle guidance

Intervention Description

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

Primary Outcome Measure Information:

Title

Block application time

Description

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 Outcome Measure Information:

Title

Number of interventions

Description

intervention from the same or another site after exiting the skin

Time Frame

up to 20 minutes

Title

The number of needle guidance

Description

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

Time Frame

up to 20 minutes

Title

sensory block

Description

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

Title

motor block

Description

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

Time Frame

up to 40 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Korgün Ökmen, Assoc. PhD.

Phone

+902242955000

korgunokmen@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Korgün Ökmen, Assoc. PhD.

Organizational Affiliation

Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bursa

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method

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