Acute Thoracic Herpes ZosterPhase 4NCT04656821
Erector Spinae Block Versus Thoracic Paravertebral Block for Acute Thoracic Herpes Zoster
A Phase 4 study testing Erector Spinae Block and Thoracic Paravertebral Block in people with Acute Thoracic Herpes Zoster and Erector Spinae Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this research is to study and compare the efficacy and safety of single injection erector spinae plane block and thoracic paravertebral block in prevention of post herpetic neuralgia in patients with acute thoracic herpes zoster. Read more about this study
- Who is it for?
- Ages 51 to 75 years
- Conditions the study is for
- Acute Thoracic Herpes Zoster, Erector Spinae Plane Block, Thoracic Paravertebral Block
- What is being tested?
- Erector Spinae Block and Thoracic Paravertebral Block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2020to 20 Jun 2021
- Phase
- Phase 4
- 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 51 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 50 years of age
- Chest wall herpetic eruption of less than one week
- Moderate or severe pain
Who cannot join
- Patient refusal
- Eruption more than one week duration
- Patients who will not receive appropriate anti-viral therapy
- Patients with mild pain
- Infection at the site of injection
- Patients with a history of renal, hepatic diseases, coagulopathy, steroid therapy, malignancies.
- Patient taking chemotherapy and/or radiotherapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta
Esraa Hassan Abdelwahab, MSc, +201010473318, esraa.hassan@med.tanta.edu.eg
About this study
Official title: Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Thoracic Paravertebral Block for Pain Relief in Patients With Acute Thoracic Herpes Zoster
The aim of this research is to study and compare the efficacy and safety of single injection erector spinae plane block and thoracic paravertebral block in prevention of post herpetic neuralgia in patients with acute thoracic herpes zoster.
- Conditions
- Acute Thoracic Herpes Zoster, Erector Spinae Plane Block, Thoracic Paravertebral Block, Pain Relief
- Being tested
- Control Rx, Erector Spinae Block, Thoracic Paravertebral Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control RxDrug
Patients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed
Erector Spinae BlockProcedure or surgery
Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography.
Thoracic Paravertebral BlockProcedure or surgery
Patients of this group will receive 25 mg bupivacaine 0.5% , plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at desired level under ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed. Receives: Drug: Control Rx |
| Erector Spinae Block (ESB) group | Experimental | Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography. The concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography. Receives: Procedure: Erector Spinae Block |
| Thoracic Paravertebral Block group | Experimental | Patients will receive 25 mg bupivacaine 0.5%, plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at the desired level under ultrasonography Receives: Procedure: Thoracic Paravertebral Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post herpetic neuralgia (PHN)
Persistent herpetic pain after 3 months will reported as post herpetic neuralgia (PHN)
Measured: 3 months
Secondary outcomes (4)
Visual Analog Scale
Visual Analog Scale (VAS) at baseline, 3, 4, 12, 24 weeks
Measured: 6 months
Total consumption of rescue analgesia
Rescue analgesia in the form of Acetaminophen in a dose of 1,000 mg will be given if Visual Analog Scale (VAS) ≥4
Measured: 6 months
The times of complete resolution of pain
The times of complete resolution of pain (from the date of block until complete disappearance of herpetic pain)
Measured: 3 months
Adverse effects and complications
- Hypotension
- Pneumothorax
- Local anesthetic toxicity
- Respiratory depression
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start5 Dec 2020
- Primary completion6 Jun 2021 (estimated)
- Study completion20 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Thoracic Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Hassan Abdelwahab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656821
- Sponsor's protocol ID
- 32720/11/18
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Thoracic Paravertebral Block for Pain Relief in Patients With Acute Thoracic Herpes Zoster
- ClinicalTrials.gov ID
- NCT04656821
- Acronym / sponsor ID
- 32720/11/18
- Conditions
- Acute Thoracic Herpes Zoster, Erector Spinae Plane Block, Thoracic Paravertebral Block, Pain Relief
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 5 Dec 2020 (actual)
- Primary completion
- 6 Jun 2021 (estimated)
- Study completion
- 20 Jun 2021 (estimated)
- First posted
- 7 Dec 2020 (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.
The aim of this research is to study and compare the efficacy and safety of single injection erector spinae plane block and thoracic paravertebral block in prevention of post herpetic neuralgia in patients with acute thoracic herpes zoster.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Control RxPatients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed. |
| Erector Spinae Block (ESB) group | Experimental | Procedure: Erector Spinae BlockPatients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography. The concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography. |
| Thoracic Paravertebral Block group | Experimental | Procedure: Thoracic Paravertebral BlockPatients will receive 25 mg bupivacaine 0.5%, plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at the desired level under ultrasonography |
Who may qualify
- Ages
- 51 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 50 years of age
- Chest wall herpetic eruption of less than one week
- Moderate or severe pain
Key exclusion criteria (7 listed)
- Patient refusal
- Eruption more than one week duration
- Patients who will not receive appropriate anti-viral therapy
- Patients with mild pain
- Infection at the site of injection
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 |
|---|---|---|
| Control RxPatients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed | Drug | Control Group |
| Erector Spinae BlockPatients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography. | Procedure or surgery | Erector Spinae Block (ESB) group |
| Thoracic Paravertebral BlockPatients of this group will receive 25 mg bupivacaine 0.5% , plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at desired level under ultrasonography | Procedure or surgery | Thoracic Paravertebral Block group |
Primary outcome
The incidence of post herpetic neuralgia (PHN)
Time frame: 3 months
Persistent herpetic pain after 3 months will reported as post herpetic neuralgia (PHN)
4 secondary outcomes
Visual Analog Scale
Time frame: 6 months
Total consumption of rescue analgesia
Time frame: 6 months
The times of complete resolution of pain
Time frame: 3 months
Adverse effects and complications
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erector Spinae Block and Thoracic Paravertebral Block in people with Acute Thoracic Herpes Zoster and Erector Spinae Plane Block, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Dec 2020. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Hassan Abdelwahab, MSc (+201010473318, esraa.hassan@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of post herpetic neuralgia (PHN) (time frame: 3 months). 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 8 Dec 2020.