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WithdrawnNCT03595046Updated Feb 12, 2019

The Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic Neuralgia

An interventional study of erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg) and thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg) in Thoracic Postherpetic Neuralgia, sponsored by Yonsei University. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-12.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
It was difficult to recruit subjects.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

Erector spinae plane block is new interfascial plane block, and can be applied to management of thoracic neuropathic pain syndromes. The target of needle is deeper(or anterior) to the erector spinae muscle. So it is more safe and simple technique than prior technique, thoracic paravertebral block. The aim of this study is the evaluation of erector spinae plane block comparison to prevertebra block.

Read the detailed description

This study is single-blind because it is not possible to blind the practitioner performing the injection.

Subjects were randomly assigned to the erector spinae plane block group (group E) and the thoracic paravertebral block group (group P) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.

Before the procedure, a resident who does not know of this study records the patient's pain and painDETECT. and on follow-up four weeks visits, PGIC scale is checked.

The erector spinae plane block or thoracic paravertebral block should be performed after receiving the informed consent of the patient.

Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner.

02

Conditions studied

  • Thoracic Postherpetic Neuralgia

Keywords

  • thoracic paravertebral block
  • erector spinae plane block
  • thoracic postherpetic neuralgia
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

Browse Neuralgia studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Inclusion criteria were patients who had chest wall post herpetic neuralgia, with moderate and severe pain and received appropriate antiviral therapy.

Exclusion criteria

Exclusion Criteria:

  1. Patient refusal
  2. Patients who did not receive appropriate antiviral therapy
  3. Patients with mild pain
  4. Heavy skin eruption (no healthy area for needle entry) and infection at site of injection.
  5. Patients with history of renal, hepatic diseases, coagulopathy, diabetes
  6. Patients taking chemotherapy and/or radiotherapy
  7. Patients with history of steroid therapy
  8. Patients taking narcotic analgesics
  9. Patient who does not understand the study because of illiteracy or language problems.
  10. Abnormal findings in peripheral blood test (CBC, ESR, CRP, PT/aPTT)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    erector spinae plane block group (group E)

    ultrasound-guided erector spinae plane block

    Procedure: erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg)

  • Active comparator
    thoracic paravertebral block group (group P)

    ultrasound-guided thoracic paravertebral block

    Procedure: thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)

Interventions

  • Procedureerector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg)

    In group E, The patient was placed in a sitting position and a high-frequency linear ultrasound transducer was placed in a longitudinal orientation 3 cm lateral to the thoracic spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle was inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between transverse process and erector spinae muscles, as evidenced by visible linear spread of fluid between erector spinae muscles and the bony acoustic shadows of the transverse process. A total of 20 mL of 0.25% ropivacaine with dexamethasone 5mg was injected here.

  • Procedurethoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)

    2) In group P, an appropriate thoracic spinous precess is located by positioning the probe in the transverse plane. Then the probe is moved laterally to locate the transverse process. The probe is manipulated slightly caudad or cephala to locate the intercostal space. The transverse process is visualized medially with the pleura dipping under the inferolateral aspect. The internal intercostal membrane, which is contiguous with the superior costotransverse ligament, was generally seen as a thin, radiopaque line extending from the transverse process, creating a wedge-shaped pocket, which represents the thoracic paravertebral space. A 22-gauge, facet-tip needle is advanced, in plane, from the lateral aspect of the ultrasound probe. When the needle pierced the internal intercostal membrane, and after aspiration demonstrated the absence of air or blood, 10 mL 0.25% ropivacaine with dexamethasone 5mg deposited in 5-mL increments.

06

What researchers measure

Primary outcomes

  1. 1. Pain score (NRS)

    1. in both groups, the patient is asked to score the pain before the procedure and 4 weeks later. And then the change of pain score is recorded. * NRS(numeric rating scale, on a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable)

    Time frame: Changes of Pain score from the procedure to 4 weeks

  2. 2. painDETECT score

    2. the patient is asked to painDETECT score the pain before the procedure and 4 weeks later. And then the change of painDETECT score is recorded. * painDETECT Questionnaire. The first five questions ask about the gradation of pain, scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5). Question 6 asks about the pain course pattern, scored from -1 to 2, depending on which pain course pattern diagram is selected. Question 7 asks about radiating pain, answered as yes or no, and scored as 2 or 0 respectively. The total score summed each subscales is between -1 and 38, indicates the likelihood of a neuropathic pain component. A score less than 12 indicates that pain is unlikely to have a neuropathic component, while a score more than 19 suggests that pain is likely to have a neuropathic component.

    Time frame: Changes of painDETECT score from the procedure to 4 weeks

  3. 3. PGIC, 7 scales(overall improvement of pain relief)

    3. the patient is asked to PGIC, 7 scales about overall improvement of pain relief 4 weeks later. * Patient's global impression of change(PGIC) scale. Since beginning treatment at this clinic, the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition. (No change =1, almost the same = 2, a little better = 3, somewhat better =4, moderate better =5, better =6, a great deal better =7)

    Time frame: Changes of PGIC, 7 scales from the procedure to 4 weeks

07

Study locations

1 site
  • Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03595046
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jul 23, 2018
Start date
Jul 2018 (estimated)
Primary completion
Apr 6, 2019 (estimated)
Completion
Jun 6, 2019 (estimated)
Last update
Feb 12, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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