Pain, Chronic
Conditions
Keywords
Pain, Lumbar, Spread
Brief summary
The primary endpoint of this study was to identify if eretor spinae plane block (ESPB) has any effect in relieving low back pain or leg pain in lumbar radiculopathy. The secondary endpoint was to compare the number of spread level when upper or lower lumbar ESPB was performed.
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. To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. However, these studies are limited by the small number of included patients. Therefore, the exact spread level of injected local anesthetics remains unclear and a study on a large number of patients is still required
Interventions
PROCEDUREErector spinae plane block
fascial plane injection guided by fluoroscopy device
Sponsors
Keimyung University Dongsan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* lumbar disc herniation * lumbar foraminal stenosis * lumbar central stenosis * lumbar spondylolisthesis * severe level of spine at L3-4 * numerical rating scale \> 4 * back pain functional scale \< 45 * duration of pain \> 1 month * patients who can fully understand all items described in BPFS
Exclusion criteria
* Allergy to local anesthetics or contrast medium * Pregnancy * Spine deformity * Prior history of lumbar spine surgery * No previous lumbar MRI or CT * Patients with coagulation abnormality * Incorrect level of ESPB
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical rating scale changes among 5 times period | baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB | numerical rating scale changes after ESPB among 5 times period |
| back pain function scale changes among 2 times period | baseline, 4 weeks after ESPB | back pain function scale changes after ESPB among 2 times period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| spread level in the cranio-caudal direction | baseline, 1 minute after ESPB | fluoroscopic contrast medium spread level in the cranio-caudal direction |
Countries
South Korea
Outcome results
None listed