Sympatholytic Effect of Thoracic ESP

Pain, Chronic Clinical Trial

Official title:

Sympatholytic Effect of High Thoracic Erector Spinae Plane Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05723393
• Other study ID #: 2023-01-025-01
• Status: Completed
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: July 10, 2023

Study information

• Verified date: July 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Procedure:
• Erector spinae plane block
fascial plane injection guided by ultrasound

Locations

Country	Name	City	State
Korea, Republic of	Ji Hoon Park	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	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
Primary	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
Primary	Perfusion index ratio at 10 minutes	Perfusion index ratio at 10 minutes	baseline, 10minutes after ESPB