Rhomboid Intercostal and Subserratus Plane Block Versus Paravertebral Block for Thoracic Herpes Zoster

NCT06751680 | Completed DMC FDA Device

• 1 other identifier: 2023-MER-301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Postherpetic neuralgia (PHN) is a common and debilitating complication of herpes zoster, characterized by persistent and severe pain. The rhomboid intercostal and subserratus plane (RISS) block, a novel ultrasound-guided regional anesthesia technique, has shown promise for various pain conditions, but its effectiveness for treating thoracic PHN remains relatively unexplored, and comparative studies against Paravertebral (PVB) block are lacking. This study aims to compare the efficacy and safety of RISS block versus PVB block for thoracic herpes zoster.

Conditions

Thoracic Herpes Zoster

Keywords

Herpes Zoster; Paravertebral Block; Postherpetic Neuralgia; Regional Anesthesia; Rhomboid Intercostal and Subserratus Plane Block

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale(NRS)

  The NRS, Numerical Rating Scale, is a rating system from 0 to 10, where 0 represents "no pain" and 10 represents the worst possible pain.

  At baseline (before therapy), on the day of treatment, at 7 days post-treatment, 30 days post-treatment, and 90 days post-treatment

Secondary Outcomes (1)

• The Zoster Brief Pain Inventory (ZBPI)

  At baseline (before therapy), on the day of treatment, at 7 days post-treatment, 30 days post-treatment, and 90 days post-treatment

Study Arms (2)

RISS group

EXPERIMENTAL

Rhomboid Intercostal and Subserratus Plane Block

Device: Rhomboid Intercostal and Subserratus Plane Block

PVB group

ACTIVE COMPARATOR

Paravertebral Block

Device: PVB block

Interventions

Rhomboid Intercostal and Subserratus Plane Block DEVICE

Upon entry, electrocardiogram (ECG), blood pressure, and oxygen saturation were monitored. The patient is placed in the prone position with their arms abducted and internally rotated. Ultrasound equipment (SonoSite Edge II; Fujifilm SonoSite, Bothell, WA, USA) with a linear 13-6 MHz transducer (HFL50x; Fujifilm SonoSite, Bothell, WA, USA) was used. Each nerve block was performed by initially injecting a 5 mL test dose, observing for clinical signs of pain relief in the affected thoracic dermatome, and then injecting the remaining volume of medication after confirmation of the injection site. Patients received ultrasound-guided nerve blocks every 48 hours, for a total of three treatments.The RISS block is a composite nerve block technique that involves two injection sites, located in the inter-rhomboid plane and the sub-serratus plane, respectively. The choice of block plane depended on the patient's site of pain.

RISS group

PVB block DEVICE

The patient is placed in the prone position with their arms abducted and internally rotated. Ultrasound equipment (SonoSite Edge II; Fujifilm SonoSite, Bothell, WA, USA) with a linear 13-6 MHz transducer (HFL50x; Fujifilm SonoSite, Bothell, WA, USA) was used. Each nerve block was performed by initially injecting a 5 mL test dose, observing for clinical signs of pain relief in the affected thoracic dermatome, and then injecting the remaining volume of medication after confirmation of the injection site. Patients received ultrasound-guided nerve blocks every 48 hours, for a total of three treatments.After confirming needle tip placement, 10 mL of 0.5% ropivacaine with 10 mg of triamcinolone acetonide was slowly injected in divided doses, observing for the spread of the local anesthetic to ensure adequate distribution within the PVS for effective block. If multiple nerves were involved, the injection sites were spaced one thoracic vertebral segment apart.

PVB group

Eligibility Criteria

• Age: 44 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with typical manifestations of herpes zoster (HZ), such as vesicular and painful rash
• herpes zoster neuralgia lasting more than one month and unresponsive to conventional treatment
• a VAS score ≥ 4
• thoracic nerve root involvement

You may not qualify if:

• refused to provide written informed consent
• unable to cooperate with assessments
• history of systemic autoimmune disease, organ transplantation, or cancer
• received other invasive treatments (e.g., spinal cord stimulation)
• central nervous system disorder
• coagulopathy
• skin infection at the puncture site
• pregnant/lactating

Sponsors & Collaborators

• Xiaguang Duan: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiangyu Wang, Undergraduate

  Inner Mongolia Baogang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Anesthesiology

Model Details: RISS group The RISS block is a composite nerve block technique that involves two injection sites, located in the inter-rhomboid plane and the sub-serratus plane, respectively. The choice of block plane depended on the patient's site of pain. PVB group Paravertebral Block

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: January 1, 2024
• Primary Completion: January 12, 2024
• Study Completion: November 30, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: January 2025-January 2027
• Access Criteria: A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.

Locations

CN (1)