Sympatholytic Effect of Thoracic ESP

Not Applicable

Completed

• Conditions: Pain, Chronic

• Registration Number: NCT05723393
• Lead Sponsor: Keimyung University Dongsan Medical Center

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.

Study Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-10
• Study Start: 2023-02-13
• Status Verified: 2023-07
• Primary Completion: 2023-07-10
• Study Completion: 2023-07-10
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ji Hoon Park; 🇰🇷 Daegu, Korea, Republic of