Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201905893503298 Date of Approval: 27/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Erector Spinae Block in Management of Herpes Zoster Pain
Official scientific title Role Of Ultrasound Guided Erector Spinae Plane Block In Management Of Herpes Zoster Pain And Incidence Of Post-herpetic Neuralgia
Brief summary describing the background and objectives of the trial Varicella zoster virus (VZV) is an exclusively human virus that belongs to the α-herpesvirus family. VZV is present worldwide and is highly infectious. Primary infection leads to acute varicella or “chickenpox”, usually from exposure either through direct contact with a skin lesion or through airborne spread from respiratory droplets. After initial infection, VZV establishes lifelong latency in cranial nerve and dorsal root ganglia, and can reactivate years to decades later as herpes zoster (HZ) or “shingles”. The virus travels from the sensory ganglion back down the nerve to the skin, where it produces the characteristic dermatomal rash of herpes zoster. Severe zoster-associated pain often limits a patient’s activities of daily living and may significantly lower functional status and quality of life. Thus, effective treatment of zoster-associated pain is highly necessary. Erector spinae plane block (ESPB) is an interfascial block developed to provide analgesia to patients suffering from pain consisting of an injection of local anaesthetic in the plane between the erector spinae muscle and the transverse process of the underlying vertebra. The aim of this study is to assess the efficacy of Ultrasound guided Erector Spinae Plane Block for pain relief.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Herpes Zoster
Purpose of the trial Treatment: Other
Anticipated trial start date 15/06/2019
Actual trial start date 15/06/2019
Anticipated date of last follow up 15/06/2020
Actual Last follow-up date 15/06/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Erector Spinae Plane Block and Standard Treatment Erector Spinae Plane Block: Using 0.25% bupivacaine 20 ml and 40 mg methyl prednisolone single shot in the thoracic dermatome corresponding to the rash. Acyclovir: 800 mg 5 times per day Pregabalin: 150 mg 2 times per day Acetaminophen: 1000 mg Erector Spinae Plane Block: Once Acyclovir : for 7 days Pregabalin: for 7 days Acetaminophen: rescue analgesia Pregabalin:: Dose of Pregabalin will be increased or decreased according to pain severity and patient’s ability to tolerate drugs, due to side effects (drowsiness, day time sleepiness, nausea and vomiting), as follows: If VAS ≤ 3 the dose of Pregabalin will be decreased by 150 mg every other day if pain score is maintained between 0 and 3. Pregabalin dose will be returned to the last controllable dose if the VAS increased to >3. Upon the patient’s request, If the VAS > 6, the block will be repeated, maximum twice, with a minimum of 2 weeks interval. Acetaminophen: will be used as a rescue medication when VAS ≥4. 20
Control Group Standard Treatment Acyclovir: 800 mg 5 times per day Pregabalin: 150 mg 2 times per day Acetaminophen: 1000 mg Acyclovir : for 7 days Pregabalin: for 7 days Acetaminophen: rescue analgesia Pregabalin:: Dose of Pregabalin will be increased or decreased according to pain severity and patient’s ability to tolerate drugs, due to side effects (drowsiness, day time sleepiness, nausea and vomiting), as follows: If VAS ≤ 3 the dose of Pregabalin will be decreased by 150 mg every other day if pain score is maintained between 0 and 3. Pregabalin dose will be returned to the last controllable dose if the VAS increased to >3. Upon the patient’s request, If the VAS > 6, the block will be repeated, maximum twice, with a minimum of 2 weeks interval. Acetaminophen: will be used as a rescue medication when VAS ≥4. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Moderate pain, Visual Analog Scale (VAS) ≥ 4 less than 5 affected dermatomes. thoracic eruption < 3 months. ASA status IV, V. coagulation abnormalities known allergy to methylprednisolone or bupivacaine serum creatinine ≥ 5 mg/dL Patients coming after ≥ 3 months after rash healing. chronic pain for any other reason requiring analgesia. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/03/2019 IRB Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Mesalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain relief Baseline, 2, 4, and 12 weeks after starting the treatment
Secondary Outcome post herpetic neuralgia At 4 and 12 weeks after starting the treatment
Secondary Outcome average dose of Pregabalin and Acetaminophen consumed 2, 4, and 12 weeks after starting the treatment
Secondary Outcome serum interleukin-6 Baseline, 2, 4, and 12 weeks after starting the treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Dermatology Department Faculty of Medicine University of Alexandria Champlion street, Raml Station., Alexandria Egypt Alexandria 21131 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mai Ahmed Mohammed ElSayed 91 Ahmed Shawky Street, Mostafa Kamel Alexandria 21523 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anaesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria 17 Champollion Street, El Messalah Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ola Mohey ElDin Zanaty 17 Champollion Street El Messalah Alexandria 21521 Egypt
Wafaa Mohamed Shafshak 17 Champollion Street El Messalah Alexandria 21521 Egypt
Rania Elsaied Abdelmaksoud 17 Champollion Street El Messalah Alexandria 21521 Egypt
Hisham Mohamed Gamal Eldine Hassan 17 Champollion Street El Messalah Alexandria 21521 Egypt
Mai Ahmed Mohammed ElSayed 91 Ahmed Shawky Street, Mostafa Kamel Alexandria 21523 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ola Zanaty Olazanaty@yahoo.com 00201148800811 17 Champollion Street El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Wafaa Shafshak Shaffshak_Waf@yahoo.com 00201005264390 17 Champollion Street El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information