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.: PACTR201611001885115 Date of Registration: 23/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title us guided ICNB with nerve stimulation for thoracic PHN
Official scientific title Intercostal nerve block under ultrasound guidance with and without nerve stimulator for the management of chronic thoracic postherpetic neuralgia :A prospective randomized controlled study.
Brief summary describing the background and objectives of the trial Post herpetic neuralgia which is one of the most common types of neuropathic pain is increasing significantly nowadays. Postherpetic neuralgia is defined as pain which lasts more than one month after the disappearance of the rash of herpes zoster . It is a common cause of pain in old people over the age of sixty. The older the age the more the increase in incidence of neuralgia . The mainstay lines of treatment of postherpetic neuralgia include acyclovir , corticosteroids , and lidoderm patch. Some interventions has been tried to control the problem like epidural steroids , paravertebral block , thoracic sympathectomy and intercostal nerve block with variable degree of success . (Peng PWH and Narouse S ) (2009) . There are 12 pairs of intercostal nerves which lie at the inferior groove of each corresponding rib . These nerves supply the skin and the intercostal muscles of the patient . The intercostal nerves (ICNs) are part of the somatic nervous system. The intercostal nerve itself is difficult to be visualized under ultrasound because they are small and covered by the corresponding rib . (Abrahams MS et al') (2010) . ). In the last decade, ultrasound guidance has gained more popularity and is used as the gold standard to perform most of the nerve blockades and apparently reduces performance time, surrogate measures of success, and complications of the other guides or blindly techniques. We hypothesis that adding nerve stimulator may be more confirmatory for the site of the nerve blocked and will increase the success of the block .Up to our knowledge and through the pub med search no previous studies have been done on the use of ultrasound block for postherpetic neuralgia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied post herpetic neuralgia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/11/2015
Actual trial start date 30/11/2015
Anticipated date of last follow up 11/04/2017
Actual Last follow-up date 23/11/2016
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
nil known IRP /Mansoura faculty of medicicne
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Simple randomisation using by using procedures such as coin-tossing or dice-rolling Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intercostal nerve block under ultrasound guidance 3 ml of bupivacaine 0.1 % with dexamethazone 2mg in 1ml each intercostal space to be blocked single injection Group U ( Ultrasonography alone ) whom will 3 ml of bupivacaine 0.1 % with dexamethazone 2mg in 1ml each intercostal space to be blocked 21 Active-Treatment of Control Group
Experimental Group Intercostal nerve block under ultrasound guidance 3 ml of bupivacaine 0.1 % with dexamethazone 2mg in 1ml each intercostal space to be blocked single injection Group Un ( Ultrasonography with nerve stimulator ) whom will 3 ml of bupivacaine 0.1 % with dexamethazone 2mg in 1ml each intercostal space to be blocked 21
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged between 40 and 75 years old ASA class I and II who have post herpetic neuralgia involving the thoracic and upper abdominal region with pain score more than 5 and not responding to the conventional medical treatment patient refusal , local or systemic infection , patients with chronic obstructive pulmonary disease , coagulopathy and also allergy to local anesthetics Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 75 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 06/12/2015 IRP , Faculty of medicine , Mansourah university
Ethics Committee Address
Street address City Postal code Country
Elgmhoria street Elmansourah 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain score immediately after the procedure, then one week , one month and every month for a duration of 3 months after the procedure
Secondary Outcome patient satisfaction one and 3 months after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansourah university hospitals , Mansourah university . Elgmhoria street ElMansourah 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansourah university Hospitals Elgmhoria street ElMansourah 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansourah university Hospitals Elgmhoria street ElMansourah 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
alaa adel elmaadawy Elgmhoria street ElMansourah 35516 Egypt
Nevert abdelghaffar Elgmhoria street ElMansourah 35516 Egypt
Ghada Elrahamawy Elgmhoria street ElMansourah 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator alaa elmaadawy a_maadawy@hotmail.com 00201153304999 Elgmhoria street
City Postal code Country Position/Affiliation
elmansourah 35516 Egypt lecturer in anesthesia , pain managment
Role Name Email Phone Street address
Public Enquiries alaa elmaadawy a_maadawy@hotmail.com 00201153304999 Elgmhoria street
City Postal code Country Position/Affiliation
elmansourah 35516 Egypt lecturer in anesthesia , pain managment
Role Name Email Phone Street address
Public Enquiries alaa elmaadawy a_maadawy@hotmail.com 00201153304999 Elgmhoria street
City Postal code Country Position/Affiliation
elmansourah 35516 Egypt lecturer in anesthesia , pain managment
REPORTING
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