- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05723380
Prediction of Clinical Outcome in Thoracic ESPB
February 13, 2023 updated by: Ji Hee Hong, Keimyung University Dongsan Medical Center
Perfusion Index Value in Predicting the Clinical Outcome of Thoracic ESPB
The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Daegu, Korea, Republic of, 42601
- Recruiting
- Ji Hoon Park
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who visited the pain clinic
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perfusion index changes among 4 time periods
Time Frame: 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
|
baseline, 10 minutes after erector spinae plane block, 20 minutes after erector spinae plane block, 30 minutes after erector spinae plane block
|
Number of patients showing numerical rating scale reduction more than 50%
Time Frame: 1 month after ESPB
|
Number of patients showing numerical rating scale reduction more than 50%
|
1 month after ESPB
|
Number of patients showing numerical rating scale reduction less than 50%
Time Frame: 1 month after ESPB
|
Number of patients showing numerical rating scale reduction less than 50%
|
1 month after ESPB
|
Number of patients showing no reduction in numerical rating scale
Time Frame: 1 month after ESPB
|
Number of patients showing no reduction in numerical rating scale
|
1 month after ESPB
|
Neck disability index changes between 2 time periods
Time Frame: baseline, 1 month after ESPB
|
Neck disability index changes between 2 time periods
|
baseline, 1 month after ESPB
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2023
Primary Completion (Anticipated)
November 30, 2023
Study Completion (Anticipated)
November 30, 2023
Study Registration Dates
First Submitted
February 3, 2023
First Submitted That Met QC Criteria
February 3, 2023
First Posted (Actual)
February 10, 2023
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-01-025-02
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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