Sympatholytic Effect of Thoracic ESP

Sympatholytic Effect of High Thoracic Erector Spinae Plane Block

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.

Study Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Procedure: Erector spinae plane block

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Ji Hoon Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20 ml T2 ESPB group; T2 ESPB group where ESPB is performed at T2 with local anesthetics 20ml	Procedure: Erector spinae plane block; fascial plane injection guided by ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale changes among 3 times period	Numerical rating scale changes among 3 times period	baseline, 30 minutes after ESPB, 2 weeks after ESPB
Perfusion index ratio at 10 minutes	Perfusion index ratio at 10 minutes	baseline, 10minutes after ESPB
Perfusion index changes among 4 times period	Perfusion index changes after T2 ESPB among 4 times period	baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Investigators: Principal Investigator: Ji H Hong, Keimyung University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2023-01-025-01

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