Prediction of Clinical Outcome in Thoracic ESPB

Pain, Chronic Clinical Trial

Official title:

Perfusion Index Value in Predicting the Clinical Outcome of Thoracic ESPB

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723380
• Other study ID #: 2023-01-025-02
• Status: Recruiting
• Start date: February 13, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2023
• Source: Keimyung University Dongsan Medical Center
• Contact: Ji H Hong
• Phone: 01046794343
• Email: swon13[@]daum.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy

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. PI has been used widely for the prediction of success of brachial plexus block or axillary block. Changes of PI ratio value showed an excellent predictive value for the success of block. There have been no studies demonstrating predictive value of PI in thoracic ESPB for the relief of cervical radiulopathy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Cervical foraminal stenosis
• Cervical central stenosis
• Cerivcal disc herniation
• Cervical spondylolisthesis

Exclusion Criteria:

• infection
• pregnancy
• allergy to local anesthetic agents
• previous cervical spine surgery

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Procedure:
• Erector spinae plane block
T2 ESPB group where ESPB is performed at T2 with local anesthetics 20ml

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 time periods	Perfusion index changes among 4 time periods	baseline, 10 minutes after erector spinae plane block, 20 minutes after erector spinae plane block, 30 minutes after erector spinae plane block
Primary	Number of patients showing numerical rating scale reduction more than 50%	Number of patients showing numerical rating scale reduction more than 50%	1 month after ESPB
Primary	Number of patients showing numerical rating scale reduction less than 50%	Number of patients showing numerical rating scale reduction less than 50%	1 month after ESPB
Primary	Number of patients showing no reduction in numerical rating scale	Number of patients showing no reduction in numerical rating scale	1 month after ESPB
Primary	Neck disability index changes between 2 time periods	Neck disability index changes between 2 time periods	baseline, 1 month after ESPB