Analysis of Injectate Spread During Erector Spinae Block

Pain Clinical Trial

Official title:

Comparison of the Spread Level During Thoracic Erector Spinae Plane Block Using Two Volumes of Local Anesthetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280847
• Other study ID #: Keimyung University
• Status: Completed
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: December 2022
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study was to identify the ESPB spread level in the craniocaudal direction when performed at the T2 level. The secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with ESPB

Description:

The ESPB requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis muscles comprise the ES muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base. The ESPB can be performed in the cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more widely compared to cervical and lumbar regions. Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side. The exact mechanism of action of ESPB remains unclear. A recent study suggested that the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. However, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of ESPB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Cervical facet joint arthrosis

• Cervical foraminal stenosis

• Cervical herniated intervertebral disc

• myofascial pain syndrome of upper back muscle

Exclusion Criteria:

• Allergy to local anesthetics or contrast medium

• Pregnancy

• Prior history of cervical spine surgery

• Coagulation abnormality

Related Conditions & MeSH terms

• Cervical
• Pain

Intervention

Procedure:
• Erector spinae plane block
fascial plane injection using ultrasound and fluoroscopic guidance

Locations

Country	Name	City	State
Korea, Republic of	Hong ji HEE	Daegu
Korea, Republic of	Ji Hee Hong	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spread level in the cranio-caudal direction	fluoroscopic contrast medium spread level in the cranio-caudal direction	baseline, 1 minutes after erector spinae plane block
Secondary	Number of participant showing epidural spread	Number of participant showing epidural spread by analysis of fluoroscopic image	baseline, 1 minute after erector spinae plane block
Secondary	Number of participant showing intercostal spread	Number of participant showing intercostal spread by analysis of fluoroscopic image	baseline, 1 minute after erector spinae plane block
Secondary	Number of participant showing paravertebral spread	Number of participant showing paravertebral spread by analysis of fluorosocpic image	baseline, 1 minute after erector spinae plane block
Secondary	Number of participant showing intravascular spread	Number of participants showing intravascular spread by analysis of fluoroscopic image	baseline, 1 minute after erector spinae plane block