Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoral Neck Fractures; Nerve Block; Lumbosacral Plexus
• Intervention / Treatment: Procedure: in-plane needle guidance; Procedure: out-of-plane needle guidance

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Korgün Ökmen, Assoc. PhD.; Phone Number: +902242955000; Email: korgunokmen@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of interventions	intervention from the same or another site after exiting the skin	up to 20 minutes
The number of needle guidance	Retraction and re-advancement of the needle after skin entry without exiting the skin	up to 20 minutes
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).	up to 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	up to 40 minutes

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): January 25, 2024
• Study Completion (Estimated): February 13, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: 2023-3/7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No