Prediction of Clinical Outcome in Lumbar ESPB

Sponsor
Keimyung University Dongsan Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05723367
Collaborator
(none)
85
1
9.5
8.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: lumbar ESPB group where ESPB is performed at L4 with local anesthetics 20ml

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
85 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Perfusion Index Value in Predicting the Clinical Outcome of Lumbar ESPB
Actual Study Start Date :
Feb 13, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Outcome Measures

Primary Outcome Measures

  1. 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]

    Perfusion index changes among 4 time periods

  2. Number of patients showing numerical rating scale reduction more than 50% [1 month after erector spinae plane block]

    Number of patients showing numerical rating scale reduction more than 50%

  3. Number of patients showing numerical rating scale reduction less than 50% [1 month after erector spinae plane block]

    Number of patients showing numerical rating scale reduction less than 50%

  4. Number of patients showing no reduction in numerical rating scale [1 month after erector spinae plane block]

    Number of patients showing no reduction in numerical rating scale

  5. Back pain functional scale between 2 time periods [baseline, 1 month after erector spinae plane block]

    Back pain functional scale between 2 time periods

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ji Hoon Park Daegu Korea, Republic of 42601

Sponsors and Collaborators

  • Keimyung University Dongsan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier:
NCT05723367
Other Study ID Numbers:
  • 2023-01-025-03
First Posted:
Feb 10, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2023