Clinical trial NCT05280847: Analysis of Injectate Spread During Erector Spinae Block
Official title: Comparison of the Spread Level During Thoracic Erector Spinae Plane Block Using Two Volumes of Local Anesthetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Cervical
Keywords: Pain
Cervical
Spread
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 159
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: spread level in the cranio-caudal direction
timeFrame: baseline, 1 minutes after erector spinae plane block
Secondary outcomes:
measure: Number of participant showing epidural spread
timeFrame: baseline, 1 minute after erector spinae plane block
measure: Number of participant showing intercostal spread
timeFrame: baseline, 1 minute after erector spinae plane block
measure: Number of participant showing paravertebral spread
timeFrame: baseline, 1 minute after erector spinae plane block
measure: Number of participant showing intravascular spread
timeFrame: baseline, 1 minute after erector spinae plane block
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
city: Daegu
country: Korea, Republic of
facility: Ji Hee Hong
Study officials:
affiliation: Keimyung University
name: Ji H Hong
role: PRINCIPAL_INVESTIGATOR
References: