Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06088368
• Other study ID #: 2023-3/7
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: February 13, 2024

Study information

• Verified date: October 2023
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: Korgün Ökmen, Assoc. PhD.
• Phone: +902242955000
• Email: korgunokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 13, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Nerve Block

Intervention

Procedure:
• in-plane needle guidance
Ultrasound -guided lumbar plexus block with in-plane needle guidance using the Shamrock method
• out-of-plane needle guidance
Ultrasound -guided lumbar plexus block with out-of-plane needle guidance using Shamrock method

Locations

Country	Name	City	State
Turkey	University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of interventions	intervention from the same or another site after exiting the skin	up to 20 minutes
Secondary	The number of needle guidance	Retraction and re-advancement of the needle after skin entry without exiting the skin	up to 20 minutes
Secondary	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
Secondary	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