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.: PACTR201508001190111 Date of Approval: 06/07/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Unilateral vs. bilateral splanchnic block for hepatobiliary cancer pain: is there a difference?
Official scientific title In patients with hepatobiliary cancer, does unilateral splanchnic block is equally effective as bilateral splanchnic bock in reduction of cancer pain ?
Brief summary describing the background and objectives of the trial we assume that the innervation of hepatobiliary tree is from right splanchnic nerves, so it is unnecessary to do bilateral block. we will compare unilateral splanchnic block with bilateral one in reduction of chronic pain
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,cancer pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/08/2015
Actual trial start date 15/08/2015
Anticipated date of last follow up 01/02/2016
Actual Last follow-up date 01/02/2016
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group bilatral splanchnic block 6 month under fluroscopic guidence we will inject 10 ml of alcohol 50% at the side of T11 vertebra between the junction of anterior and middle third of vertebral body. the whole procedure will be done in the other side 25 Active-Treatment of Control Group
Experimental Group unilateral splanchnic block 6 month under fluroscopic guidence we will inject 10 ml of alcohol 50% at the side of T11 vertebra between the junction of anterior and middle third of vertebral body 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with hepatobiliary cancer coagulopathy infection at site of injection allergy to study drugs 20 Year(s) 90 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
No 30/07/2015 SECI
Ethics Committee Address
Street address City Postal code Country
10 el mthaque st., 71111 assuit 71111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduction of pain intensity assessed by VAS scale immediately after intervention 2 days 1 week 2 week 1 month 2 month 3 month 4 month 5 month 6 month
Secondary Outcome opioid consumption after procedure by 1 week, 2 week, 1 month,2 month,3 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
south egypt cancer institute 10 el methaque st., 71111. assuit city assuit 71111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
none
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor diab fuad hetta 10 soliman hakeem street, assuit city, 71111, egypt assuit 71111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
fatma el zahraa 5 elhelaly st., 55 . assuit city assuit 55 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator diab hetta diabhetta25@gmail.com +201091090009 10 soliman hakeem street, assuit city, 71111, egypt
City Postal code Country Position/Affiliation
assuit 71111 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries diab hetta diabhetta25@gmail.com +201091090009 10 soliman hakeem street, assuit city, 71111, egypt
City Postal code Country Position/Affiliation
assuit 71111 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries diab hetta diabhetta25@gmail.com +201091090009 10 soliman hakeem street, assuit city, 71111, egypt
City Postal code Country Position/Affiliation
assuit 71111 Egypt lecturer
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information