Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain.

NCT06307444 | Completed DMC

• 1 other identifier: stellate block and ESP block
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.

Conditions

Acute Herpes Zoster Pain Managment

Outcome Measures

Primary Outcomes (1)

• reduction of a numeric rating scale (NRS) pain score

  1. Pain intensity before block by NRS score (0-10) 2. Pain intensity after block by NRS score (0-10) Pain intensity at 1,2,3,4, ,6,8,12 and24 weeks

  after the porcedure till 12 weak

Study Arms (3)

medical treatment only

NO INTERVENTION

All patients will receive oral medication for antiviral therapy (800mg of acyclovir 5 times daily) at the time of diagnosis and supportive treatments, including acetaminophen (1gm 3times daily), and gabapentin (starting at 100mg three times daily) to be incrementally up titrated over time as needed by 100 to 300 mg every 3 to 5 days, to as high a dosage as 1800 to 3600 mg/day in 3 or 4 divided doses

Ultrasound-Guided Stellate Ganglion Block

EXPERIMENTAL

Ten milliliters of a local anesthetic solution (bupivacaine (0.25%)+ 8 mg dexamethasone) is injected until the fluid spreads along the paravertebral fascia to the stellate ganglion.

Procedure: Ultrasound-Guided Stellate Ganglion Block

Group III T2 T3 (High Thorathic) ErectroSpinae Plan Block

EXPERIMENTAL

ocal anesthetic drugs(0.2-0.3ml/kg of bupivacaine 0.25% 8mg Dexamethazone) will be administered as standard in all patients aiming to distribute within the plane between the anterior fascia of the erector spinae muscle and the transverse process.

Procedure: T2 T3 (High Thorathic) ESP Block

Interventions

Ultrasound-Guided Stellate Ganglion Block PROCEDURE

high frequency (6 to 13 MHz) linear transducer will be placed perpendicular to the tracheal axis at the cricoid cartilage and will be moved inferiorly until the superior aspect of the thyroid gland is visualized. Later, the transducer should be relocated laterally to visualize the anterior aspect of the Chassaignac's tubercle on \[\]the C6 transverse process. The carotid artery, internal jugular vein, thyroid gland, trachea, Longus colli, and Longus capitis muscle, prevertebral fascia, the root of C6 spinal nerve, and transverse process of C6 can be identified. Color Doppler will be used to detect the position of the vessels. With an in-plane approach, 22 to 25 gauge echo-enhanced needle is placed beside the trachea with a lateral to medial direction.

Ultrasound-Guided Stellate Ganglion Block

T2 T3 (High Thorathic) ESP Block PROCEDURE

We will count the laminae in the cephaled-to-caudal direction, starting from the C7 using the US to determine the exact vertebral level where the needle will be inserted. A linear high-frequency ultrasound probe will be used to perform the blocks. After the determination of the needle insertion site, the US probe was placed over the spinous processes of the vertebrae at the midline in the longitudinal plane. The US probe will then slid laterally from the spinous processes to visualize the transverse process. The needle will be advanced posterior-to-anteriorly, in the caudal to cephalic direction using the in-plane orientation within paraspinal muscles, targeting the transverse process. When the tip of the needle reaches and contact the transverse process, the local anesthetic drugs(0.2-0.3ml/kg(11) of bupivacaine 0.25% 8mg Dexamethazone) will be administered

Group III T2 T3 (High Thorathic) ErectroSpinae Plan Block

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over the age of 21 with upper limb herpetic eruption lasting shorter than a week along with moderate to severe pain who got adequate antiviral medications

You may not qualify if:

• We will exclude patients who refuse to participate, those who are taking anticoagulant medications, have secondary bacterial infections of the dermatome, those who have an allergy to local anesthetics or serious disease of the heart ( e.g. heart block), lung, kidneys and those who had a history of neck surgery, such as thyroid cancer.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university faculty of medicine

Tanta, None Selected, 31527, Egypt

Location

Study Officials

• Aliaa M Belal, MD

  tanta univ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 12, 2024
• Study Start: March 20, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

EG (1)