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Comparison of Pain Relief and Peripheral Perfusion Index

Comparison of Pain Relief and Peripheral Perfusion Index Using Different Volume of Erector Spinae Plane Block

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06471907
Enrollment
64
Registered
2024-06-24
Start date
2024-06-13
Completion date
2025-04-30
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erector Spinea Plane Block

Brief summary

The primary endpoint of this study is to compare the pain relief and peripheral perfusion index using different volume of local anesthetics in 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. 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. Perfusion index is an indirect method which can present the degree of peripheral perfusion. Moreover, it is known as a more sensitive measurement tool than the rise of skin temperature. The apply of perfusion index is very simple and noninvasive. The degree of PI increase has been used to determine the success of peripheral nerve block. The volume of local anesthetics has been used 10-30 ml. However, most effective dosage with proper pain relief has never been suggested.

Interventions

PROCEDUREerector spinae plane block

fascial plane injection using ultrasound

Sponsors

Keimyung University Dongsan Medical Center
Lead SponsorOTHER

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 * numerical rating scale \> 4 * back pain functional scale \< 45 * duration of pain \> 1 mon * patients who can fully understand all items described in back pain functional scale

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

Design outcomes

Primary

MeasureTime frameDescription
Numerical rating scale changes among 5 times periodBaseline, 2 weeks, 4 weeks, 8 weeks after the completion of erector spine plane blockminimum (1) and maximum value (10), lower score means better outcome

Secondary

MeasureTime frameDescription
back pain functional scale among 3 times periodBaseline, 4 weeks, 8 weeks after the completion of erector spine plane blockminimum (0) and maximum value (60), higher score means better outcome
Perfusion index changes among 4 times periodbaseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPBerfusion index changes after lumbar ESPB among 4 times period

Countries

South Korea

Contacts

Primary ContactJi H Hong
swon13@daum.net01046794343
Backup ContactJi Hoon Park
cmjihoon@gmail.com0532587760

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026