Comparison of Injection Spread of Thoracic Erector Spinae Plane Block

Sponsor

Keimyung University Dongsan Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05487313

Collaborator

(none)

Enrollment

Location

Arms

8.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary endpoint of this study was to identify erector spinae plane block (ESPB) spread level in the cranio-caudal direction. The secondary endpoint was to identify the incidence of spread of epidural, intercostal, paravertebral space, and intravascular injections with thoracic ESPB.

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic	Procedure: Erector spinae plane block	N/A

Detailed Description

The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities.

To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. However, these studies are limited by the small number of included patients. Therefore, the exact spread level of injected local anesthetics remains unclear and a study on a large number of patients is still required.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Injection Spread of Thoracic Erector Spinae Plane Block With Various Volumes of Local Anesthetics

Actual Study Start Date :

Feb 12, 2022

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 10 ml ESP group ESP group using 10 ml mixture of local anesthetics and contrast medium	Procedure: Erector spinae plane block fascial plane injection guided by fluoroscopic device
Active Comparator: 20 ml ESP group ESP group using 20 ml mixture of local anesthetics and contrast medium	Procedure: Erector spinae plane block fascial plane injection guided by fluoroscopic device

Arm

Intervention/Treatment

Active Comparator: 10 ml ESP group

ESP group using 10 ml mixture of local anesthetics and contrast medium

Procedure: Erector spinae plane block

fascial plane injection guided by fluoroscopic device

Active Comparator: 20 ml ESP group

ESP group using 20 ml mixture of local anesthetics and contrast medium

Procedure: Erector spinae plane block

fascial plane injection guided by fluoroscopic device

Outcome Measures

Primary Outcome Measures

spread level in the cranio-caudal direction [1 minutes after erector spinae plane block]
fluoroscopic contrast medium spread level in the cranio-caudal direction

Secondary Outcome Measures

Number of participant showing epidural spread [baseline, 1 minute after erector spinae plane block]
Number of participant showing epidural spread by analysis of fluoroscopic image
Number of participant showing intercostal spread [baseline, 1 minute after erector spinae plane block]
Number of participant showing intercostal spread by analysis of fluoroscopic image
Number of participant showing paravertebral spread [baseline, 1 minute after erector spinae plane block]
Number of participant showing paravertebral spread by analysis of fluorosocpic image

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

cervical spinal stenosis
cervical disc herniation
cervical facet arthropathy
myofascial pain syndrome of upper back muscle

Exclusion Criteria:

Allergy to local anesthetics or contrast medium
Pregnancy
Spine deformity
Patients with coagulation abnormality

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hong ji HEE	Daegu		Korea, Republic of	42601

Sponsors and Collaborators

Keimyung University Dongsan Medical Center

Investigators

Principal Investigator: Ji H Hong, Ph.D, Keimyung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center

ClinicalTrials.gov Identifier:

NCT05487313

Other Study ID Numbers:

2022-01-026-02

First Posted:

Aug 4, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center

Pain, Cervical, Spread

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Aug 4, 2022