NCT06476080

Brief Summary

Acute herpes zoster pain is very severe . Conventional analgesics may be of no value. Regional blocks may play a role

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

July 5, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

June 15, 2024

Last Update Submit

June 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain score

    Visual analogue scale from 0 to 10. 0= NO pain, 1-3=mild tolerable pain, 4-6= moderate pain, 7-10= severe untearable pain.

    immediate after injection, 1 week, 1, 3 months

Secondary Outcomes (3)

  • Number of patients with pain recurrence

    1 week, 1, and 3 months

  • analgesic consumption

    1 week, 1, and 3 months

  • Incidence of treatment related adverse events

    immediately after injection

Study Arms (3)

Control group

NO INTERVENTION

800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion)

Erector spinae group

ACTIVE COMPARATOR

800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion)+ 25 ml bupivacaine 0.25% plus 8 mg dexamethasone

Procedure: ultrasound guided erector spine block

Serratus anterior group

ACTIVE COMPARATOR

800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion)+ 25 ml bupivacaine 0.25% plus 8 mg dexamethasone

Procedure: Serratus anterior block

Interventions

Ultrasound guided thoracic erector spinae block

Erector spinae group

Ultrasound guided serratus anterior block

Serratus anterior group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult population between 30 and 75 years old.
  • Unilateral painful thoracic herpetic eruption of less than one week duration.
  • VAS more than or equal 4, persistent pain in spite of proper antiviral and analgesic therapy, (800 mg oral acyclovir, 5 times per day, for one week), pregabalin 300 mg per day, acetaminophen 1000 mg per day, topical calamine lotion).

You may not qualify if:

  • Diabetic patients.
  • Painful herpetic eruptive vesicles more than one week.
  • Abdominal herpetic eruptions.
  • Non-compliant on anti-viral (bulbar palsy for example).
  • Co-malignancy or radiotherapy.
  • Steroid therapy \> 5 mg prednisolone or its equivalent.
  • Infections or hematoma at site of injection.
  • Coagulopathy (chronic kidney or liver disease, clopidogrel use).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass professor anesthesia and pain

Study Record Dates

First Submitted

June 15, 2024

First Posted

June 26, 2024

Study Start

July 5, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

June 27, 2024

Record last verified: 2024-06