Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06088368

Collaborator

(none)

Enrollment

Location

Arms

3.8

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Femoral Neck Fractures Lumbosacral Plexus Nerve Block	Procedure: in-plane needle guidance Procedure: out-of-plane needle guidance	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 20, 2023

Anticipated Primary Completion Date :

Jan 25, 2024

Anticipated Study Completion Date :

Feb 13, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: in-plane needle guidance Ultrasound -guided lumbar plexus block	Procedure: in-plane needle guidance Ultrasound -guided lumbar plexus block with in-plane needle guidance using the Shamrock method
Active Comparator: out-of-plane needle guidance Ultrasound -guided lumbar plexus block	Procedure: out-of-plane needle guidance Ultrasound -guided lumbar plexus block with out-of-plane needle guidance using Shamrock method

Arm

Intervention/Treatment

Active Comparator: in-plane needle guidance

Ultrasound -guided lumbar plexus block

Procedure: in-plane needle guidance

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

Active Comparator: out-of-plane needle guidance

Ultrasound -guided lumbar plexus block

Procedure: out-of-plane needle guidance

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

Outcome Measures

Primary Outcome Measures

Block application time [up to 20 minutes]
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 [up to 20 minutes]
intervention from the same or another site after exiting the skin
The number of needle guidance [up to 20 minutes]
Retraction and re-advancement of the needle after skin entry without exiting the skin
sensory block [up to 40 minutes]
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 [up to 40 minutes]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,	Bursa		Turkey

Sponsors and Collaborators

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

Principal Investigator: Korgün Ökmen, Assoc. PhD., Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Korgün Ökmen, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT06088368

Other Study ID Numbers:

2023-3/7

First Posted:

Oct 18, 2023

Last Update Posted:

Oct 18, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Femoral Neck Fractures

Study Results

No Results Posted as of Oct 18, 2023