Rhomboid Intercostal and Subserratus Plane Block Versus Paravertebral Block for Thoracic Herpes Zoster
NCT ID: NCT06751680
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2024-01-01
2024-11-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PVB group Paravertebral Block
TREATMENT
QUADRUPLE
Study Groups
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RISS group
Rhomboid Intercostal and Subserratus Plane Block
Rhomboid 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.
PVB group
Paravertebral Block
PVB 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.
Interventions
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Rhomboid 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.
PVB 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.
Eligibility Criteria
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Inclusion Criteria
* herpes zoster neuralgia lasting more than one month and unresponsive to conventional treatment
* a VAS score ≥ 4
* thoracic nerve root involvement
Exclusion Criteria
* 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
44 Years
82 Years
ALL
No
Sponsors
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Xiaguang Duan
OTHER
Responsible Party
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Xiaguang Duan
Deputy Chief of Anesthesiology
Principal Investigators
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Xiangyu Wang, Undergraduate
Role: PRINCIPAL_INVESTIGATOR
Inner Mongolia Baogang Hospital
Locations
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Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, China
Countries
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Other Identifiers
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2023-MER-301
Identifier Type: -
Identifier Source: org_study_id