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Sympatholytic Effect of Thoracic ESP

Primary Purpose

Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erector spinae plane block
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Complex regional pain syndrome Post-thoracotomy pain syndrome Cervical foraminal stenosis Cervical disc herniation Herpes zoster Exclusion Criteria: Pregnacy Coagulation abormality Previous spine surgery Allergy to local anesthetics

Sites / Locations

  • Ji Hoon Park

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

20 ml T2 ESPB group

Arm Description

T2 ESPB group where ESPB is performed at T2 with local anesthetics 20ml

Outcomes

Primary Outcome Measures

Perfusion index changes among 4 times period
Perfusion index changes after T2 ESPB among 4 times period
Numerical rating scale changes among 3 times period
Numerical rating scale changes among 3 times period
Perfusion index ratio at 10 minutes
Perfusion index ratio at 10 minutes

Secondary Outcome Measures

Full Information

First Posted
February 2, 2023
Last Updated
July 10, 2023
Sponsor
Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05723393
Brief Title
Sympatholytic Effect of Thoracic ESP
Official Title
Sympatholytic Effect of High Thoracic Erector Spinae Plane Block
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
July 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary endpoint of this study was to identify if erector spinae plane bloock (ESPB) demonstrates any sympatholytic effect. The secondary endpoint of this study was to compare the changes of PI value between responders and non-responders.
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. The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively. ESPB can achieve analgesic effect by blocking the ventral and doramal ramus and possibly by diffusion into paravertebral space. In constrast to lumar region, thoracic paravertebral space is very close to the sympathetic chain. Therefore, sympatholytic effect might be achieved by thoracic ESPB. No previous study has demonstrated the sympatholytic effect of ESPB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20 ml T2 ESPB group
Arm Type
Experimental
Arm Description
T2 ESPB group where ESPB is performed at T2 with local anesthetics 20ml
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
fascial plane injection guided by ultrasound
Primary Outcome Measure Information:
Title
Perfusion index changes among 4 times period
Description
Perfusion index changes after T2 ESPB among 4 times period
Time Frame
baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB
Title
Numerical rating scale changes among 3 times period
Description
Numerical rating scale changes among 3 times period
Time Frame
baseline, 30 minutes after ESPB, 2 weeks after ESPB
Title
Perfusion index ratio at 10 minutes
Description
Perfusion index ratio at 10 minutes
Time Frame
baseline, 10minutes after ESPB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complex regional pain syndrome Post-thoracotomy pain syndrome Cervical foraminal stenosis Cervical disc herniation Herpes zoster Exclusion Criteria: Pregnacy Coagulation abormality Previous spine surgery Allergy to local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji H Hong
Organizational Affiliation
Keimyung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ji Hoon Park
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Sympatholytic Effect of Thoracic ESP

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