Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000377639
Ethics application status
Approved
Date submitted
20/03/2014
Date registered
8/04/2014
Date last updated
1/11/2019
Date data sharing statement initially provided
1/11/2019
Date results information initially provided
1/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of repeated paravertebral injections with local anesthetics and steroids on prevention of post-herpetic neuralgia
Scientific title
Effect of repeated paravertebral injections with local anesthetics and steroids on prevention of post-herpetic neuralgia in patients over 50 with chest wall herpetic eruption
Secondary ID [1] 284293 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chest wall herpetic eruption
291439 0
post-herpetic neuralgia 291551 0
Condition category
Condition code
Anaesthesiology 291814 291814 0 0
Pain management
Infection 291855 291855 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive paravertebral block using 25 mg bupivacaine 0.5% plus 8 mg dexamethasone in a total volume of 10 ml three times one week apart under fluoroscopy
Intervention code [1] 289016 0
Prevention
Intervention code [2] 289056 0
Treatment: Drugs
Comparator / control treatment
Patients will receive paravertebral block using either 25 mg bupivacaine 0.5% plus 8 mg dexamethasone in a total volume of 10 ml twice one week apart under fluoroscopy
Control group
Active

Outcomes
Primary outcome [1] 291728 0
Lower the incidence of post herpetic neuralgia which will be evaluated by visual analogue scale
Timepoint [1] 291728 0
Assessed before the block (basal), 1 hour after the block, every 3 days for 2 weeks after the procedure and every week for 6 weeks and after 3 and 6 months.
Secondary outcome [1] 307361 0
Pain severity was assessed using Visual Analogue Scale (VAS), (10 cm unmarked line in which 0 = no pain and 10 cm=worst pain imaginable
Timepoint [1] 307361 0
Before the block (basal), 1 hour after the block, every 3 days for 2 weeks after the procedure and every week for 6 weeks and after 3 and 6 months
Secondary outcome [2] 307600 0
Analgesic consumption was assessed by patient self-report
Timepoint [2] 307600 0
Before the block (basal), 1 hour after the block, every 3 days for 2 weeks after the procedure and every week for 6 weeks and after 3 and 6 months

Eligibility
Key inclusion criteria
Inclusion criteria: patients over 50 who had chest wall herpetic eruption of less than one week, with moderate and severe pain and received appropriate antiviral therapy.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patient refusal, eruption of more than one week duration, patients who did not receive appropriate antiviral therapy, patients with mild pain, heavy skin eruption (no healthy area for needle entry) and infection at site of injection. Patients with history of renal, hepatic diseases, coagulopathy, diabetes, steroid therapy, malignancies and patients taking chemo and/or radiotherapy will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A blinded pain physician will determine if a subject was eligible for inclusion in the trial.

Patients will be randomly assigned using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly assigned using a computer-generated random number assignment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size will be determined assuming that the expected incidence of PHN in patients above 50 years old in the control group was 22.1% to 30 %. (1-5) An average incidence of 26% will be considered. Our aim will be to lower the incidence to less than 5% at power of study 90% (a = 0.05, B = 0.1). A calculated sample size of 34 patients in each group will be needed. We will include 80 patients to overcome losses during follow-up period.
Statistical analyses will be carried out based on the intention to treat using SPSS version 16 (SPSS Inc., Chicago, IL, USA). Mean (SD) will be used to summarize continuous quantitative data and frequency and proportion will be used for qualitative data. The analysis of the data will be done to test statistical significant differences between the two groups. For quantitative data, unpaired student t- test will be used to compare between the two groups. For qualitative data, chi-square test will be used. P-value < 0.05 will considered significant.
1- Ji G, Niu J, Shi Y, Hou L, Lu Y, Xiong L. The effectiveness of repetitive paravertebral injections with local anesthetics and steroids for the prevention of postherpetic neuralgia in patients with acute herpes zoster. Anesth Analg 2009;109:1651-5.
2- van Wijck AJ, Opstelten W, Moons KG, van Essen GA, Stolker RJ, Kalkman CJ, Verheij TJ. The PINE study of epidural steroids and local anaesthetics to prevent postherpetic neuralgia: a randomised controlled trial. Lancet. 2006; 367(9506):219-24.
3- Pasqualucci A, Pasqualucci V, Galla F, et al. Prevention of postherpetic neuralgia: acyclovir and prednisolone versus epidural local anesthetic and methylprednisolone. Acta Anaesthesiol Scand 2000; 44: 910–18.
4- Makharita Y.M, Amr MY, and El-Bayoumy Y. Effect of early stellate ganglion block blockade for acute herpes zoster of the face on intensity, duration of acute pain and incidence of PHN: Double blind randomized trial. Pain Physician 2012; 15:467-474.
5- Makharita Y.M, Amr MY, and El-Bayoumy Y. Single paravertebral injection for acute thoracic herpes zoster: A randomized controlled trial. Pain Practice (In press)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2014
Actual
3/01/2015
Date of last participant enrolment
Anticipated
Actual
7/01/2017
Date of last data collection
Anticipated
Actual
7/01/2018
Sample size
Target
80
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 5911 0
Egypt
State/province [1] 5911 0

Funding & Sponsors
Funding source category [1] 288927 0
Self funded/Unfunded
Name [1] 288927 0
Country [1] 288927 0
Primary sponsor type
Individual
Name
Mohamed Y. Makharita
Address
Faculty Of Medicine - El Mansoura University - 60 El Gomhoureya St.
El Mansoura, El Dakahleya
Post code 35516
Country
Egypt
Secondary sponsor category [1] 287619 0
None
Name [1] 287619 0
Address [1] 287619 0
Country [1] 287619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290755 0
medical research ethical committe- Mansoura university
Ethics committee address [1] 290755 0
Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El Mansoura
, El Dakahleya
Post code 35516
Ethics committee country [1] 290755 0
Egypt
Date submitted for ethics approval [1] 290755 0
26/02/2014
Approval date [1] 290755 0
18/03/2014
Ethics approval number [1] 290755 0
R/82

Summary
Brief summary
This randomized double blind clinical trial will be carried out at Mansoura University Hospital After approval from the Institutional Ethical Committee and obtaining of written, informed consent, 80 adult patients with acute herpes zoster affecting the chest wall will be referred from the dermatology clinic after prescribing appropriate antiviral therapy (acyclovir 800 mg five times daily administered orally for 7 days within the first 72 hours of eruption).
Inclusion criteria: patients over 50 who had chest wall herpetic eruption of less than one week, with moderate and severe pain and received appropriate antiviral therapy.
Exclusion criteria includes: patient refusal, eruption of more than one week duration, patients who did not receive appropriate antiviral therapy, patients with mild pain, heavy skin eruption (no healthy area for needle entry) and infection at site of injection. Patients with history of renal, hepatic diseases, coagulopathy, diabetes, steroid therapy, malignancies and patients taking chemo and/or radiotherapy will be excluded.
Patients will be randomly assigned using a computer-generated random number assignment to receive paravertebral block using either 25 mg bupivacaine 0.5% plus 8 mg dexamethasone in a total volume of 10 ml twice one week apart under fluoroscopy ( Group 1) or 25 mg bupivacaine 0.5% plus 8 mg dexamethasone in a total volume of 10 ml three times one week apart under fluoroscopy ( Group 2).
All patients will receive pregabalin in a dose of 150 mg/ twice with gradual reduction of the dose as the pain controlled. Acetaminophine was available as rescue analgesia in a dose of 1000 mg on request.
Patients will be evaluated for pain severity using Visual Analogue Scale (VAS), (10 cm unmarked line in which 0 = no pain and 10 cm=worst pain imaginable) before the block (basal), 1 hour after the block, every 3 days for 2 weeks after the procedure and every week for 6 weeks and after 3 and 6 months.
At each assessment visit, the total analgesic consumption will be recorded. The times of complete resolution of pain (from the date of paravertebral block till complete disappearance of herpetic pain) and skin eruption (identified by drop of last crust) will be recorded. The incidence of persistent herpetic pain after 3 and 6 months will be also reported as PHN.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47074 0
A/Prof Mohamed Y. Makharita
Address 47074 0
Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El Mansoura
, El Dakahleya
postal code: 35516
Country 47074 0
Egypt
Phone 47074 0
+20507929966
Fax 47074 0
Email 47074 0
[email protected]
Contact person for public queries
Name 47075 0
A/Prof Yasser M. amr
Address 47075 0
Departments of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Tanta University. El-Geish street, Tanta. 31527.
Country 47075 0
Egypt
Phone 47075 0
+201224462887
Fax 47075 0
Email 47075 0
[email protected]
Contact person for scientific queries
Name 47076 0
A/Prof Yasser M. amr
Address 47076 0
Departments of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Tanta University. El-Geish street, Tanta. 31527.
Country 47076 0
Egypt
Phone 47076 0
+201224462887
Fax 47076 0
Email 47076 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
raw line-by-line data collected from each participant, and is typically de-identified.
When will data be available (start and end dates)?
Immediately after publication and ending 3 years from main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any statistical analysis
How or where can data be obtained?
by emailing the principal investigator
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.