Comparison of Pain Relief and Peripheral Perfusion Index

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

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.

Study Overview

• Status: Recruiting
• Conditions: Erector Spinea Plane Block
• Intervention / Treatment: 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. 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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ji H Hong; Phone Number: 01046794343; Email: swon13@daum.net
• Study Contact Backup: Name: Ji Hoon Park; Phone Number: 0532587760; Email: cmjihoon@gmail.com

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Recruiting
    • Hong Ji Hee
    • Contact: J Hee Hong; Phone Number: 82-53-258-7767; Email: swon13@daum.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 10 ml lumbar ESPB group; lumbar ESPB was performed with 10 ml of local anesthetics	Procedure: erector spinae plane block; fascial plane injection using ultrasound
Experimental: 20 ml lumbar ESPB group; lumbar ESPB was performed with 20 ml of local anesthetics	Procedure: erector spinae plane block; fascial plane injection using ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale changes among 5 times period	minimum (1) and maximum value (10), lower score means better outcome	Baseline, 2 weeks, 4 weeks, 8 weeks after the completion of erector spine plane block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfusion index changes among 4 times period	erfusion index changes after lumbar ESPB among 4 times period	baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB
back pain functional scale among 3 times period	minimum (0) and maximum value (60), higher score means better outcome	Baseline, 4 weeks, 8 weeks after the completion of erector spine plane block

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-04-007-003

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