Clinical trial NCT03595046: The Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic Neuralgia
Official title: The Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Thoracic Postherpetic Neuralgia
Keywords: thoracic paravertebral block
erector spinae plane block
thoracic postherpetic neuralgia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: erector spinae plane block group (group E) thoracic paravertebral block group (group P)
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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:

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)

Primary outcomes:
measure: 1. Pain score (NRS)
timeFrame: Changes of Pain score from the procedure to 4 weeks
measure: 2. painDETECT score
timeFrame: Changes of painDETECT score from the procedure to 4 weeks
measure: 3. PGIC, 7 scales(overall improvement of pain relief)
timeFrame: Changes of PGIC, 7 scales from the procedure to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References: