Clinical trial NCT05723367: Prediction of Clinical Outcome in Lumbar ESPB
Official title: Perfusion Index Value in Predicting the Clinical Outcome of Lumbar ESPB
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Chronic
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who visit the pain clinic

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

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 lumbar ESPB ESPB for the relief of low back pain or leg pain due to lumbar disc herniation or stenosis.

Eligibility criteria: Inclusion Criteria:

* Lumbar foraminal stenosis
* Lumbar central stenosis
* Lumbar disc herniation
* Lumbar spondylolisthesis

Exclusion Criteria:

* Infection
* Pregnancy
* allergy to local anesthetic agnets
* Previous lumbar spine surgery

Primary outcomes:
measure: Perfusion index changes among 4 time periods
timeFrame: baseline, 10 minutes after erector spinae plane block, 20 minutes after erector spinae plane block, 30 minutes after erector spinae plane block
measure: Number of patients showing numerical rating scale reduction more than 50%
timeFrame: 1 month after erector spinae plane block
measure: Number of patients showing numerical rating scale reduction less than 50%
timeFrame: 1 month after erector spinae plane block
measure: Number of patients showing no reduction in numerical rating scale
timeFrame: 1 month after erector spinae plane block
measure: Back pain functional scale between 2 time periods
timeFrame: baseline, 1 month after erector spinae plane block
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Ji Hoon Park
Study officials:
References: