Thoracic Herpes ZosterNCT06751680
Rhomboid Intercostal and Subserratus Plane Block Versus Paravertebral Block for Thoracic Herpes Zoster
A study testing Rhomboid Intercostal and Subserratus Plane Block and PVB block in people with Thoracic Herpes Zoster, run by Xiaguang Duan at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 44 to 82 years
- Conditions the study is for
- Thoracic Herpes Zoster
- What is being tested?
- Rhomboid Intercostal and Subserratus Plane Block and PVB block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rhomboid Intercostal and Subserratus Plane Block Versus Paravertebral Block for Thoracic Herpes Zoster: a Randomized Comparative Trial
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
- Conditions
- Thoracic Herpes Zoster
- Being tested
- Rhomboid Intercostal and Subserratus Plane Block, PVB block
- Keywords
- Herpes Zoster, Paravertebral Block, Postherpetic Neuralgia, Regional Anesthesia, Rhomboid Intercostal and Subserratus Plane Block
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid Intercostal and Subserratus Plane BlockDevice
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.
PVB blockDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RISS group | Experimental | Rhomboid Intercostal and Subserratus Plane Block Receives: Device: Rhomboid Intercostal and Subserratus Plane Block |
| PVB group | Active comparator | Paravertebral Block Receives: Device: PVB block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline (before therapy), on the day of treatment, at 7 days post-treatment, 30 days post-treatment, and 90 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Jan 2024
- Primary completion12 Jan 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaguang Duan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaguang Duan, Inner Mongolia Baogang Hospital
- Investigators
- Xiangyu Wang, Undergraduate, Principal investigator, Inner Mongolia Baogang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751680
- Sponsor's protocol ID
- 2023-MER-301
- Status last verified
- Nov 2024
- First submitted
- 20 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhomboid Intercostal and Subserratus Plane Block Versus Paravertebral Block for Thoracic Herpes Zoster: a Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT06751680
- Acronym / sponsor ID
- 2023-MER-301
- Conditions
- Thoracic Herpes Zoster
- Keywords
- Herpes Zoster, Paravertebral Block, Postherpetic Neuralgia, Regional Anesthesia, Rhomboid Intercostal and Subserratus Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Xiaguang DuanUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| RISS group | Experimental | Device: Rhomboid Intercostal and Subserratus Plane BlockRhomboid Intercostal and Subserratus Plane Block |
| PVB group | Active comparator | Device: PVB blockParavertebral Block |
Who may qualify
- Ages
- 44 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhomboid Intercostal and Subserratus Plane BlockUpon 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. | Device | RISS group |
| PVB blockThe 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. | Device | PVB group |
Primary outcome
Numerical Rating Scale(NRS)
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
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.
1 secondary outcome
The Zoster Brief Pain Inventory (ZBPI)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangyu Wang, Undergraduate principal investigator
Inner Mongolia Baogang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhomboid Intercostal and Subserratus Plane Block and PVB block in people with Thoracic Herpes Zoster, run by Xiaguang Duan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale(NRS) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.