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

NCT ID: NCT03595046

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2019-06-06

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.

Conditions

Thoracic Postherpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

erector spinae plane block group (group E)

ultrasound-guided erector spinae plane block

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

thoracic paravertebral block group (group P)

ultrasound-guided thoracic paravertebral block

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2018-0383

Identifier Type: -

Identifier Source: org_study_id