Prediction of Clinical Outcome in Thoracic ESPB

• Sponsor: Keimyung University Dongsan Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05723380
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Anticipated Duration (Months): 9.5
• Patients Per Site Per Month: 7.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic	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. 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

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Perfusion Index Value in Predicting the Clinical Outcome of Thoracic ESPB
• Actual Study Start Date: Feb 13, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Outcome Measures

Primary Outcome Measures

1. 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]

   Perfusion index changes among 4 time periods

2. Number of patients showing numerical rating scale reduction more than 50% [1 month after ESPB]

   Number of patients showing numerical rating scale reduction more than 50%

3. Number of patients showing numerical rating scale reduction less than 50% [1 month after ESPB]

   Number of patients showing numerical rating scale reduction less than 50%

4. Number of patients showing no reduction in numerical rating scale [1 month after ESPB]

   Number of patients showing no reduction in numerical rating scale

5. Neck disability index changes between 2 time periods [baseline, 1 month after ESPB]

   Neck disability index changes between 2 time periods

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ji Hoon Park	Daegu		Korea, Republic of	42601

Sponsors and Collaborators

• Keimyung University Dongsan Medical Center

Investigators

• Principal Investigator: Ji H Hong, Keimyung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center
• ClinicalTrials.gov Identifier: NCT05723380
• Other Study ID Numbers: 2023-01-025-02
• First Posted: Feb 10, 2023
• Last Update Posted: Feb 15, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Feb 15, 2023