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

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.

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Changes of Pain score from the procedure to 4 weeks
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.	Changes of painDETECT score from the procedure to 4 weeks
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)	Changes of PGIC, 7 scales from the procedure to 4 weeks

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): April 6, 2019
• Study Completion (ANTICIPATED): June 6, 2019

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (ACTUAL): July 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: thoracic paravertebral block; erector spinae plane block; thoracic postherpetic neuralgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Ropivacaine
• Other Study ID Numbers: 4-2018-0383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No