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Pain Relief and Injectate Spread During Erector Spinae Block

Sponsor
Keimyung University Dongsan Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05280847
Collaborator
(none)
50
Enrollment
3
Locations
2
Arms
11.6
Anticipated Duration (Months)
16.7
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to identify whether the ESP block has advantage in improving the symptoms of cervical radiculopathy and to compare the injectate spread between 10 ml and 20 ml mixture of local anesthetics and contrast medium.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector spinae plane block
 N/A

Detailed Description

Erector spinae plane (ESP) block has been highlighted as one of the fascial plane block since the first introduction into clinical field in 2016. The ESP block involves ultrasound guided injection of a relatively large volume of local anesthetics (0.3-0.5 ml/kg) into the fascial plane between the tips of the transverse process and erector spinae muscle. Local anesthetics spreads within this potential space over 3-6 vertebral levels in a craniocaudal direction. Medial-lateral spread is usually confined to the boundaries of the erector spinae muscle. Previous reports suggest that this results in somatic and visceral analgesia in the territory supplied by the congruent spinal nerves.

The mechanism of action proposed in the early descriptions of the ESP block was of local anesthetic spread anteriorly from the plane of injection, through channels in the intertransverse connective tissues, to the paravertebral space, where it could act on ventral rami and spinal nerve roots. However, this has been challenged by recent cadaveric studies and results of inconsistent cutaneous sensory loss in clinical studies.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Pain Relief and Pattern of Injectate Spread Using Different Volume of Erector Spinae Plane Block
Actual Study Start Date :
Feb 10, 2022
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 10 ml ESP group

ESP group using 10 ml mixture of local anesthetics and contrast medium

Procedure: Erector spinae plane block
fascial plane injection using ultrasound guidance
Other Names:
  • ESP

    		•
    Active Comparator: 20 ml ESP group

    ESP group using 20 ml mixture of local anesthetics and contrast medium

    Procedure: Erector spinae plane block
    fascial plane injection using ultrasound guidance
    Other Names:
  • ESP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes of numerical rating scale (1-10) [baseline, 10 minutes after erector spinae plane block, 1 week after erector spinae plane block, 2 weeks after erector spinae plane block, 4 weeks after erector spinae plane block, 6 weeks after erector spinae plane block]

      Changes of numerical rating scale of cervical radiculopathy

    Secondary Outcome Measures

    1. Number of participant showing epidural spread [baseline, 1 minute after erector spinae plane block]

      Number of participant showing epidural spread by analysis of fluoroscopic image

    2. Number of participant showing intercostal spread [baseline, 1 minute after erector spinae plane block]

      Number of participant showing intercostal spread by analysis of fluoroscopic image

    3. Number of participant showing paravertebral spread [baseline, 1 minute after erector spinae plane block]

      Number of participant showing paravertebral spread by analysis of fluorosocpic image

    Eligibility Criteria

    Criteria

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

    • Cervical spinal stenosis

    • Cervical disc herniation

    • Patients with NRS > 4

    • Pain duration > 4 month

    • Patinets who can understand questionaire

    • Identifiable cervical lesion according to MRI

    Exclusion Criteria:

    • Allergy to local anesthetics or contrast medium

    • Pregnancy

    • Spine deformity

    • Patients who requiring hemodialysis

    • Neurologic abnromality

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hong ji HEE Daegu Korea, Republic of 42601
    2 Hong ji HEE Daegu Korea, Republic of 42601
    3 Ji Hee Hong Daegu Korea, Republic of 700712

    Sponsors and Collaborators

    • Keimyung University Dongsan Medical Center

    Investigators

    • Principal Investigator: Ji H Hong, Keimyung University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keimyung University Dongsan Medical Center
    ClinicalTrials.gov Identifier:
    NCT05280847
    Other Study ID Numbers:
    • Keimyung University
    First Posted:
    Mar 15, 2022
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Feb 1, 2022
    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
    Keywords provided by Keimyung University Dongsan Medical Center
    Pain
    Cervical
    Spread

    Study Results

    No Results Posted as of Aug 2, 2022