Multimodal Nerve Block and Pulse Radiofrequency for Acute Herpes Zoster Pain

NCT06798662 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2024-MER-314
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical trial is to evaluate the efficacy of liposomal bupivacaine and ropivacaine in the treatment of pain associated with herpes zoster (shingles). This trial will also assess the safety profiles of both liposomal bupivacaine and ropivacaine. The study aims to address the following key questions: Does nerve blockade with liposomal bupivacaine or ropivacaine reduce the required dosage of gabapentin in participants? What medical issues, if any, arise in participants undergoing paravertebral block, intercostal nerve block, RISS (Radiofrequency Intervention for Spinal Segment); or pulsed radiofrequency (PRF)? Can nerve blocks, specifically paravertebral block, intercostal nerve block, RISS; and PRF, effectively treat severe postherpetic neuralgia (PHN)? The study will compare these interventions. Study Procedures: Participants will:Receive ultrasound-guided nerve blocks or pulsed radiofrequency every 48 hours, for a total of 3 treatments. Undergo assessments, either in-person or via telephone, at the following time points: before therapy (baseline), on the day of treatment (Day 1), Day 7, Day 30, and Day 90 post-treatment. Have their symptoms recorded, along with their scores on the Numerical Rating Scale (NRS) and the Zoster Brief Pain Inventory (ZBPI).

Conditions

Herpes Zoster (HZ)

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), at 1 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), at 1 day of treatment,, at 7 days post-treatment, 30 days post-treatment, and 90 days post-treatment

Study Arms (4)

RISS group

EXPERIMENTAL

Rhomboid Intercostal and Subserratus Plane (RISS) Block: The RISS block is a composite nerve block technique that involves two injection sites: the inter-rhomboid plane and the sub-serratus plane. The selection of block plane was determined by the patient's specific location of pain. Rhomboid Intercostal Plane Block (RIPB): For the Rhomboid Intercostal Plane Block (RIPB), a high-frequency linear ultrasound transducer was initially positioned in a sagittal orientation, medial to the scapular border. It was then slightly rotated to obtain an oblique sagittal view (oblique paramedian sagittal view), located 1-2 cm lateral to the scapular border. Upon obtaining the appropriate ultrasound image, the following anatomical structures were identified sequentially, from superficial to deep: the trapezius muscle, the rhomboid muscles (specifically, the major rhomboid), the intercostal muscles (located between the ribs), the pleura, and the lung. The target injection plane was the fascial plan

Device: Rhomboid Intercostal and Subserratus Plane (RISS) Block (2% ropivacaine or 133 mg of liposomal bupivacaine); Drug: Drug (famciclovir and gabapentin)

PVB group

EXPERIMENTAL

For the Paravertebral (PVB) block, a high-frequency linear ultrasound transducer was placed transversely, parallel to the spinous processes, approximately 2-3 cm lateral to the spinous process of the target thoracic vertebral segment. The position and angle of the transducer were adjusted to clearly visualize the transverse process (TP) and the axial view of the lamina of the target vertebra. In the ultrasound image, the transverse process appeared as a hyperechoic structure, typically with a characteristic acoustic shadow posterior to it. Subsequently, the transducer was slightly slid caudally, causing the transverse process and its acoustic shadow to gradually disappear from view. At this point, the ultrasound image revealed components of the paravertebral space (PVS), including the parietal pleura, the superior costotransverse ligament, and the intercostal fascia, which exhibited a heterogeneous mixed echogenicity. Using an in-plane technique, a puncture needle was advanced from la

Device: Paravertebral (PVB) Block (2% ropivacaine or 133 mg of liposomal bupivacaine); Drug: Drug (famciclovir and gabapentin)

ICN group

EXPERIMENTAL

The patient is positioned in either the lateral decubitus or sitting position, with the affected side facing upwards, ensuring adequate exposure of the targeted intercostal region. A high-frequency linear ultrasound transducer is placed transversely over the posterior lateral aspect of the targeted rib, using the vertebral column as a reference point. The transducer is then scanned laterally to identify the target rib, clearly visualizing the rib, intercostal muscles, and pleura. The intercostal nerve appears as a small hyperechoic structure located between the internal and innermost intercostal muscles. The needle is advanced until it contacts the inferior border of the rib. The needle is then slightly withdrawn and positioned between the internal and innermost intercostal muscles to avoid pleural puncture. After negative aspiration, 10 mL of 0.5% ropivacaine (or 133 mg of liposomal bupivacaine) combined with 10 mg of triamcinolone acetonide is injected slowly.

Device: Intercostal nerve block (2% ropivacaine or 133 mg of liposomal bupivacaine); Drug: Drug (famciclovir and gabapentin)

PRF group

EXPERIMENTAL

A high-frequency linear ultrasound transducer will be used for this procedure. The transducer will be placed transversely over the target rib area to obtain a clear visualization of the rib, intercostal muscles, and pleura. The entry point for needle insertion will be selected 1-2 cm inferior to the inferior border of the target rib. Using a 22G radiofrequency (RF) needle, an in-plane approach will be used for needle advancement. The needle will be advanced slowly until it reaches the inferior border of the rib. The needle will then be withdrawn 1-2 mm to ensure the needle tip is positioned adjacent to the intercostal nerve. The RF needle will then be connected to the RF generator for sensory testing. Stimulation parameters will be set at 50 Hz and 0.5-1V. The target location will be considered accurate if stimulation induces pain in the participant. Pulsed radiofrequency treatment will then be administered using the following parameters: voltage of 45V, frequency of 2 Hz, pulse width

Device: Ultrasound-Guided Pulsed Radiofrequency (PRF); Drug: Drug (famciclovir and gabapentin)

Interventions

Ultrasound-Guided Pulsed Radiofrequency (PRF) DEVICE

A high-frequency linear ultrasound transducer will be used for this procedure. The transducer will be placed transversely over the target rib area to obtain a clear visualization of the rib, intercostal muscles, and pleura. The entry point for needle insertion will be selected 1-2 cm inferior to the inferior border of the target rib. Using a 22G radiofrequency (RF) needle, an in-plane approach will be used for needle advancement. The needle will be advanced slowly until it reaches the inferior border of the rib. The needle will then be withdrawn 1-2 mm to ensure the needle tip is positioned adjacent to the intercostal nerve. The RF needle will then be connected to the RF generator for sensory testing. Stimulation parameters will be set at 50 Hz and 0.5-1V. The target location will be considered accurate if stimulation induces pain in the participant. Pulsed radiofrequency treatment will then be administered using the following parameters: voltage of 45V, frequency of 2 Hz, pulse width

PRF group

Intercostal nerve block (2% ropivacaine or 133 mg of liposomal bupivacaine) DEVICE

The patient is positioned in either the lateral decubitus or sitting position, with the affected side facing upwards, ensuring adequate exposure of the targeted intercostal region. A high-frequency linear ultrasound transducer is placed transversely over the posterior lateral aspect of the targeted rib, using the vertebral column as a reference point. The transducer is then scanned laterally to identify the target rib, clearly visualizing the rib, intercostal muscles, and pleura. The intercostal nerve appears as a small hyperechoic structure located between the internal and innermost intercostal muscles. The needle is advanced until it contacts the inferior border of the rib. The needle is then slightly withdrawn and positioned between the internal and innermost intercostal muscles to avoid pleural puncture. After negative aspiration, 10 mL of 0.5% ropivacaine (or 133 mg of liposomal bupivacaine) combined with 10 mg of triamcinolone acetonide is injected slowly.

ICN group

Paravertebral (PVB) Block (2% ropivacaine or 133 mg of liposomal bupivacaine) DEVICE

For the Paravertebral (PVB) block, a high-frequency linear ultrasound transducer was placed transversely, parallel to the spinous processes, approximately 2-3 cm lateral to the spinous process of the target thoracic vertebral segment. The position and angle of the transducer were adjusted to clearly visualize the transverse process (TP) and the axial view of the lamina of the target vertebra. In the ultrasound image, the transverse process appeared as a hyperechoic structure, typically with a characteristic acoustic shadow posterior to it. Subsequently, the transducer was slightly slid caudally, causing the transverse process and its acoustic shadow to gradually disappear from view. At this point, the ultrasound image revealed components of the paravertebral space (PVS), including the parietal pleura, the superior costotransverse ligament, and the intercostal fascia, which exhibited a heterogeneous mixed echogenicity. Using an in-plane technique, a puncture needle was advanced from lat

PVB group

Rhomboid Intercostal and Subserratus Plane (RISS) Block (2% ropivacaine or 133 mg of liposomal bupivacaine) DEVICE

The RISS block is a composite nerve block technique that involves two injection sites: the inter-rhomboid plane and the sub-serratus plane. The selection of block plane was determined by the patient's specific location of pain. Rhomboid Intercostal Plane Block (RIPB): For the Rhomboid Intercostal Plane Block (RIPB), a high-frequency linear ultrasound transducer was initially positioned in a sagittal orientation, medial to the scapular border. It was then slightly rotated to obtain an oblique sagittal view (oblique paramedian sagittal view), located 1-2 cm lateral to the scapular border. Upon obtaining the appropriate ultrasound image, the following anatomical structures were identified sequentially, from superficial to deep: the trapezius muscle, the rhomboid muscles (specifically, the major rhomboid), the intercostal muscles (located between the ribs), the pleura, and the lung. The target injection plane was the fascial plane situated between the rhomboid muscle and the intercostal

RISS group

Drug (famciclovir and gabapentin) DRUG

All patients will receive famciclovir and gabapentin. All participants will receive standard antiviral therapy with famciclovir 500 mg orally three times daily for 7 days. Gabapentin will be initiated at a typical starting dose of 300 mg per day, administered in three divided doses. The dosage may be gradually increased, as needed and tolerated, up to a maximum dose of 1800 mg per day.

ICN group; PRF group; PVB group; RISS group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of typical clinical manifestations of herpes zoster (shingles), including vesicular and painful rash.
• Diagnosis of postherpetic neuralgia (PHN) lasting for more than one month, unresponsive to conventional treatment.
• Visual Analog Scale (VAS) score ≥ 4.
• Involvement of thoracic nerve roots.

You may not qualify if:

• Refusal to provide written informed consent.
• Inability to cooperate with study assessments.
• History of systemic autoimmune disease, organ transplantation, or cancer.
• Prior receipt of other invasive pain treatments, such as spinal cord stimulation.
• Presence of a central nervous system (CNS) disorder.
• Presence of coagulopathy.
• Skin infection at the puncture site.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Xiaguang Duan: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

Related Publications (10)

• Russo M, Graham B, Santarelli DM. Gabapentin-Friend or foe? Pain Pract. 2023 Jan;23(1):63-69. doi: 10.1111/papr.13165. Epub 2022 Oct 27.

  PMID: 36300903 BACKGROUND

• Elhouty MG, Elbahrawy K, Elawady MS. Rhomboid intercostal block versus serratus block for postoperative analgesia after thoracoscopic sympathectomy for primary palmar hyperhidrosis: a randomized controlled trial. BMC Anesthesiol. 2023 Jul 19;23(1):241. doi: 10.1186/s12871-023-02203-z.

  PMID: 37468840 BACKGROUND

• Rosamilia LL. Herpes Zoster Presentation, Management, and Prevention: A Modern Case-Based Review. Am J Clin Dermatol. 2020 Feb;21(1):97-107. doi: 10.1007/s40257-019-00483-1.

  PMID: 31741185 BACKGROUND

• Asada H. Recent topics in the management of herpes zoster. J Dermatol. 2023 Mar;50(3):305-310. doi: 10.1111/1346-8138.16666. Epub 2022 Dec 20.

  PMID: 36539935 BACKGROUND

• Okmen K, Gurbuz H, Ozkan H. Application of unilateral rhomboid intercostal and subserratus plane block for analgesia after laparoscopic cholecystectomy: a quasi-experimental study. Korean J Anesthesiol. 2022 Feb;75(1):79-85. doi: 10.4097/kja.21229. Epub 2021 Jul 20.

  PMID: 34283910 BACKGROUND

• Wang X, Turner EL, Li F. Designing individually randomized group treatment trials with repeated outcome measurements using generalized estimating equations. Stat Med. 2024 Jan 30;43(2):358-378. doi: 10.1002/sim.9966. Epub 2023 Nov 27.

  PMID: 38009329 BACKGROUND

• Patil A, Goldust M, Wollina U. Herpes zoster: A Review of Clinical Manifestations and Management. Viruses. 2022 Jan 19;14(2):192. doi: 10.3390/v14020192.

  PMID: 35215786 BACKGROUND

• Li SJ, Feng D. Comparison of two distinct needle tip positions in pulsed radiofrequency for herpes zoster-related pain. CNS Neurosci Ther. 2023 Jul;29(7):1881-1888. doi: 10.1111/cns.14146. Epub 2023 Mar 7.

  PMID: 36880287 BACKGROUND

• Boezaart AP, Lucas SD, Elliott CE. Paravertebral block: cervical, thoracic, lumbar, and sacral. Curr Opin Anaesthesiol. 2009 Oct;22(5):637-43. doi: 10.1097/ACO.0b013e32832f3277.

  PMID: 19680122 BACKGROUND

• Xue M, Yuan R, Yang Y, Qin Z, Fu R. Application of ultrasound-guided thoracic paravertebral block or intercostal nerve block for acute herpes zoster and prevention of post-herpetic neuralgia: A case-control retrospective trial. Scand J Pain. 2024 Jul 9;24(1). doi: 10.1515/sjpain-2024-0030. eCollection 2024 Jan 1.

  PMID: 38981512 BACKGROUND

MeSH Terms

Conditions

Herpes Zoster

Interventions

Dental Occlusion; Pharmaceutical Preparations; Famciclovir; Gabapentin

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Xiaguang Duan, Master's degree

CONTACT

+86 13314720012; alonlord2023@gmail.com

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

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 29, 2025
• Study Start: February 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 10, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2026-January 2031
• Access Criteria: A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.

Locations

CN (1)