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

Primary Purpose

Thoracic Postherpetic Neuralgia

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg)
thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thoracic Postherpetic Neuralgia focused on measuring thoracic paravertebral block, erector spinae plane block, thoracic postherpetic neuralgia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

erector spinae plane block group (group E)

thoracic paravertebral block group (group P)

Arm Description

ultrasound-guided erector spinae plane block

ultrasound-guided thoracic paravertebral block

Outcomes

Primary Outcome Measures

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)
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.
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)

Secondary Outcome Measures

Full Information

First Posted
June 14, 2018
Last Updated
February 8, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03595046
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
It was difficult to recruit subjects.
Study Start Date
July 2018 (Anticipated)
Primary Completion Date
April 6, 2019 (Anticipated)
Study Completion Date
June 6, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Postherpetic Neuralgia
Keywords
thoracic paravertebral block, erector spinae plane block, thoracic postherpetic neuralgia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
erector spinae plane block group (group E) thoracic paravertebral block group (group P)
Masking
ParticipantInvestigator
Masking Description
The subjects were randomly assigned to erector spinae plane block group (group E) and thoracic paravertebral block group (group P), and the assigned results are unknown. The Outcomes Assessor is not related to the study, and does not know its contents.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
erector spinae plane block group (group E)
Arm Type
Experimental
Arm Description
ultrasound-guided erector spinae plane block
Arm Title
thoracic paravertebral block group (group P)
Arm Type
Active Comparator
Arm Description
ultrasound-guided thoracic paravertebral block
Intervention Type
Procedure
Intervention Name(s)
erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)
Intervention Description
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.
Primary Outcome Measure Information:
Title
1. Pain score (NRS)
Description
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
Title
2. painDETECT score
Description
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
Title
3. PGIC, 7 scales(overall improvement of pain relief)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: Patient refusal Patients who did not receive appropriate antiviral therapy Patients with mild pain Heavy skin eruption (no healthy area for needle entry) and infection at site of injection. Patients with history of renal, hepatic diseases, coagulopathy, diabetes Patients taking chemotherapy and/or radiotherapy Patients with history of steroid therapy Patients taking narcotic analgesics Patient who does not understand the study because of illiteracy or language problems. Abnormal findings in peripheral blood test (CBC, ESR, CRP, PT/aPTT)
Facility Information:
Facility Name
Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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