A Comparison of Visualization Between Shamrock Technique and Paramedian Transverse Scan in Lumbar Plexus Blockade

Lumbar Plexus Blockade Clinical Trial

Official title:

A Comparison of Visualization Between Shamrock Technique and Paramedian Transverse Scan in Lumbar Plexus Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982031
• Other study ID #: 302/2559(EC4)
• Status: Completed
• Phase: N/A
• First received: September 18, 2016
• Last updated: December 1, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study was to compare ultrasound visibility of the lumbar plexus at the intertransverse space between paramedian transverse scan and shamrock technique. Moreover obtaining a clear image of relevant structures is imperative. Thus, the secondary objective was to assess ultrasound visibility of each relevant structure and overall visibility between these two methods.

Description:

Background: Ultrasound-guided lumbar plexus block (USG LPB) is regarded as a form of advanced ultrasound-guided regional anesthesia (USGRA). One of the key challenges of USG LPB is visualization of the lumbar plexus. That are currently in use for ultrasound-guided lumbar plexus blockade - paramedian transverse scan (PMTS) and shamrock technique.

Method: Twenty-three healthy adult volunteers aged ≥ 18 years were enrolled in this prospective cohort study. Ultrasound visualization results were compared between methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy volunteer, age >/= 18

Exclusion Criteria:

• spinal deformity and history of previous back or spine surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lumbar Plexus Blockade

Intervention

Procedure:
• shamrock
This scanning technique is performed in the lateral decubitus position with the side of interest facing upwards. The transducer is placed in the transverse plane on the flank of the patient cranially to the iliac crest. The quadratus lumborum muscle is identified medial to the aponeurosis of the transversus abdominis muscle. With the psoas muscle anterior to the transverse process, the erector spinae muscle posterior to the transverse process, and the quadratus lumborum muscle attached to the apex of the transverse process of L4.
• paramedian transverse scan
The ultrasound transducer is positioned 4 cm lateral to the midline along the intercristal line and just above the iliac crest. The transducer is also directed slightly medially.

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Video (VDO) loops visualization of lumbar plexus	Percentage of Video (VDO) loops visualization of lumbar plexus comparing between two techniques	1 month	Yes
Secondary	Ultrasound visibility score of each relevant structures	10 structures: Erector spinae muscle, Quadratus lumborum muscle, Psoas muscle, Vertebral body, Inferior vena cava, Articular process of the lumbar vertebra, Lumbar paravertebral space, lumbar nerve root, Lumbar plexus nerve, Psoas compartment Using 4-point Likert scale (0, not visible; 1, hardly visible; 2, well visible; 3, very well visible)	1 month	Yes
Secondary	Overall ultrasound visibility score of 10 structures	Sum of ultrasound visibility score of 10 relevant structures: Erector spinae muscle, Quadratus lumborum muscle, Psoas muscle, Vertebral body, Inferior vena cava, Articular process of the lumbar vertebra, Lumbar paravertebral space, lumbar nerve root, Lumbar plexus nerve, Psoas compartment	1 month	Yes