Pain Relief After High Thoracic Eretor Spinae Block

Pain, Chronic Clinical Trial

Official title:

Comparison of Pain Relief During High Thoracic Erector Spinae Plane Block Using Different Volumes of Local Anesthetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05487313
• Other study ID #: 2022-01-026-02
• Status: Completed
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: March 21, 2023

Study information

• Verified date: March 2023
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary endpoint of this study was to identify if the ESPB in the patients of cervical radiculopathy has the effect of pain relief. The secondary endpoint of this study was to identify the spread level in the craniocaudal direction when performed at the T2 level.

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 (1,10). 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: 82
• Est. completion date: March 21, 2023
• Est. primary completion date: March 21, 2023
• 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

• Chronic Pain
• Pain, Chronic

Intervention

Procedure:
• Erector spinae plane block
fascial plane injection guided by fluoroscopic device after ultrasound guidance

Locations

Country	Name	City	State
Korea, Republic of	Hong ji HEE	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	numerical rating scale changes among 5 times period	numerical rating scale changes after T2 ESPB among 5 times period	baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB, 8 weeks after ESPB
Primary	Neck disability scale changes	Neck disability scale changes after T2 ESPB among 2 times period	baseline, 8 weeks after ESPB
Secondary	spread level in the cranio-caudal direction	fluoroscopic contrast medium spread level in the cranio-caudal direction	baseline, 1 minute after erector spinae plane block