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

Not Applicable

Withdrawn

• Conditions: Thoracic Postherpetic Neuralgia
• Interventions: Procedure: thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg); Procedure: erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg)

• Registration Number: NCT03595046
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study First Submitted: 2018-06-14
• Study Start: 2018-07
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-12
• Primary Completion: 2019-04-06
• Study Completion: 2019-06-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thoracic paravertebral block group (group P)	thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)	ultrasound-guided thoracic paravertebral block
erector spinae plane block group (group E)	erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg)	ultrasound-guided erector spinae plane block

Primary Outcome Measures

Name	Time	Method
1. Pain score (NRS)	Changes of Pain score from the procedure to 4 weeks	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)
3. PGIC, 7 scales(overall improvement of pain relief)	Changes of PGIC, 7 scales from the procedure to 4 weeks	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)
2. painDETECT score	Changes of painDETECT score from the procedure to 4 weeks	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.

Trial Locations

Locations (1)

Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of