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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

chest wall herpetic eruption

post-herpetic neuralgia

Condition category

Condition code

Anaesthesiology

Pain management

Infection

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]

Prevention

Intervention code [2]

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]

Lower the incidence of post herpetic neuralgia which will be evaluated by visual analogue scale

Timepoint [1]

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]

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]

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]

Analgesic consumption was assessed by patient self-report

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

medical research ethical committe- Mansoura university

Ethics committee address [1]

Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El Mansoura
, El Dakahleya
Post code 35516

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

26/02/2014

Approval date [1]

18/03/2014

Ethics approval number [1]

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

A/Prof Mohamed Y. Makharita

Address

Faculty Of Medicine - El Mansoura University. 60 El Gomhoureya St. El Mansoura , El Dakahleya postal code: 35516

Country

Egypt

Phone

+20507929966

Fax

[email protected]

Contact person for public queries

Name

Yasser M. amr

Address

Departments of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Tanta University. El-Geish street, Tanta. 31527.

Country

Egypt

Phone

+201224462887

Fax

[email protected]

Contact person for scientific queries

Name

Yasser M. amr

Address

Departments of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Tanta University. El-Geish street, Tanta. 31527.

Country

Egypt

Phone

+201224462887

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?

• raw line-by-line data collected from each participant, and is typically de-identified.

What types of analyses could be done with individual participant data?

• any statistical analysis

When can requests for individual participant data be made (start and end dates)?

From:
Immediately after publication and ending 3 years from main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• by emailing the principal investigator
[email protected]

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically