Analysis of Injectate Spread During Erector Spinae Block

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

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

Study Overview

• Status: Completed
• Conditions: Pain; Cervical
• Intervention / Treatment: Procedure: Erector spinae plane block

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Hong ji HEE
  • Daegu, Korea, Republic of, 700712
    • Ji Hee Hong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 ml ESP group; ESP group using 10 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy	Procedure: Erector spinae plane block; fascial plane injection using ultrasound and fluoroscopic guidance; Other Names: ESP
Experimental: 20 ml ESP group; ESP group using 20 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy	Procedure: Erector spinae plane block; fascial plane injection using ultrasound and fluoroscopic guidance; Other Names: ESP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: March 5, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Cervical; Spread
• Other Study ID Numbers: Keimyung University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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