ClinicalTrials.gg
CompletedNCT06751680Updated Dec 30, 2024

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

An interventional study of Rhomboid Intercostal and Subserratus Plane Block and PVB block in Thoracic Herpes Zoster, sponsored by Xiaguang Duan. Completed at 1 site in China. Open to participants aged 44 Years to 82 Years. Per ClinicalTrials.gov, last updated 2024-12-30.

Sponsored by Xiaguang Duan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jan 2024, 2 years 10 months ago, and no results have been posted to the registry.
  • Registered 11 months after the study started (first participant enrolled Jan 2024, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
44 Years to 82 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 51 studies in Herpes Zoster with a site in China — 26 open to participants now, 31 under way, 3 of them phase 3. Herpes Zoster · China.

Enrollment
41st of 45
30 · median 519
Started
2024
with 8 others
No phase
19 of 51
14 open now
Registered
24th of 51
by date
Lead sponsor
2 of 51
Xiaguang Duan

Among the 51 studies in Herpes Zoster with a site in China, this one is the 41st largest by enrollment of the 45 interventional ones that give a count, is one of 9 that started in 2024, is one of 19 with no phase, and was the 24th registered.

Herpes Zoster

299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.

Browse Herpes Zoster studies →

Open to participants now

26 of the 51 studies in Herpes Zoster with a site in China are open now. Recruiting first, the newest first:

21 more — sign in →

All 26 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 37 Herpes Zoster studies recruiting now, 26 (70%) set no upper age limit and 6 (16%) stop at 75 or younger; 3 take children under 18; 13 take healthy volunteers.

This study: 44 Years to 82 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

This is a prospective, randomized, comparative, double-blinded (patient and clinician), superiority and non-inferiority clinical trial. This study compares the superiority and non-inferiority of RISS block versus PVB block for analgesia in the context of PHN. Patients were recruited from Baogang Hospital, Inner Mongolia. This study was approved by the Medical Ethics Committee of Baogang Hospital, Inner Mongolia (2023-MER-301) on December 19, 2023, and adhered to the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All participants provided informed consent voluntarily.

Thirty patients with PHN, classified as ASA I-III, aged 44-82 years, and scheduled to receive either a RISS block or a PVB block between January 2024 and November 2024, were selected, with 15 patients per group. Inclusion criteria: 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; and thoracic nerve root involvement. Exclusion criteria: Patients who refused to provide written informed consent; were unable to cooperate with assessments; had a history of systemic autoimmune disease, organ transplantation, or cancer; had received other invasive treatments (e.g., spinal cord stimulation); had a central nervous system disorder; had coagulopathy; had a skin infection at the puncture site; or were pregnant/lactating.

Patients with PHN refractory to pharmacological treatment were considered for either RISS block or PVB block. All patients received famciclovir and gabapentin. Patients received standard antiviral treatment with famciclovir 500 mg three times daily for 7 days. Gabapentin was initiated at a dose of 300 mg/day, typically divided into three administrations. The dose was gradually increased to a maximum of 1800 mg/day as needed and tolerated. All procedures were performed in an outpatient operating room, and all participating physicians had undergone standardized training. 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.

Follow-up assessments were conducted at the pain clinic by two specially trained nurses who were blinded to patient allocation, at baseline (before therapy), on the day of treatment (Day 1), and at 7 days (Day 7), 30 days (Day 30), and 90 days (Day 90) post-treatment, either in person or via telephone.

Primary outcomes

03

Conditions studied

  • Thoracic Herpes Zoster

Keywords

  • Herpes Zoster
  • Paravertebral Block
  • Postherpetic Neuralgia
  • Regional Anesthesia
  • Rhomboid Intercostal and Subserratus Plane Block
04

Who can participate

Ages eligible
44 Years to 82 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • refused to provide written
  • unable to cooperate with assessments
  • history of systemic 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    RISS group

    Rhomboid Intercostal and Subserratus Plane Block

    Device: Rhomboid Intercostal and Subserratus Plane Block

  • Active comparator
    PVB group

    Paravertebral Block

    Device: PVB block

Interventions

  • DeviceRhomboid Intercostal and Subserratus Plane Block

    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.

  • DevicePVB block

    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.

06

What researchers measure

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.

    Time frame: 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)

    The daily activity questionnaire included seven items: general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life. Each question concerning daily activity was scored on a scale from 0 to 10, where 0 indicated no interference and 10 indicated complete interference.

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

07

Study locations

1 site
  • Inner Mongolia Baogang Hospital
    Baotou, Inner Mongolia 014010, China
08

References and documents

Individual participant data

Plan to share: Yes — All collected IPD, all IPD that underlie results in a publication

Supporting information: Study protocol, Statistical analysis plan

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Jan 2024, 0 months.

Of 34 interventional studies with no phase under Herpes Zoster, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2024
First posted
Dec 30, 2024
StartActual
Jan 1, 2024
Primary completionActual
Jan 12, 2024
CompletionActual
Nov 30, 2024
Last update
Dec 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06751680
Lead sponsor
Xiaguang Duan
Responsible party
Xiaguang Duan (Deputy Chief of Anesthesiology, Inner Mongolia Baogang Hospital) — Sponsor-investigator
First posted
Dec 30, 2024
Start date
Jan 1, 2024
Primary completion
Jan 12, 2024
Completion
Nov 30, 2024
Last update
Dec 30, 2024

Study contacts

Xiangyu Wang, Undergraduate
principal investigator · Inner Mongolia Baogang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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