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.: PACTR201511001257724 Date of Approval: 08/09/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title DRG radiofrequency ablation versus paravertebral thoracic nerve RF ablation
Official scientific title Thoracic rhizotomy versus thoracic paravertebral nerve radiofrequency ablation in thoracic cancer somatic pain
Brief summary describing the background and objectives of the trial the is debate regarding mechanism of action of radiofrequency ablation.moreover, animal trials showed changes in dorsal root ganglia when ablation was made very proximal at the peripheral nerve. This study aims at evaluating the degree of pain relief in 2 different techniques with varying difficulty. Clearly, the DRG is quietly more challenging
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/09/2014
Actual trial start date 07/09/2014
Anticipated date of last follow up 02/03/2014
Actual Last follow-up date 27/04/2014
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
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 simple randomisation using a table sealed envelope Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group RF DRG 67 degree celsius for 60 seconds radiofrequency ablation 15 Active-Treatment of Control Group
Experimental Group RFof thoracic paravertebral nerve 67 degree 60 seconds radiofrequency ablation 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 18 years to 60 years duration of pain was more than 3 months visual analogue scale (VAS) was more than 5 on 0-10 scale despite medical treatment or intolerability to medical treatment . interspinal extension of the tumor patient refusal lack of understanding by the patient of the purpose of the study coagulopathy local infection Intraoperative exclusion criteria were failure either to localize or to get the anterior epidural space or the paravertebral space by image guidance and dye confirmation. 18 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 07/07/2015 institutional review board decision , national cancer institute, cairo university
Ethics Committee Address
Street address City Postal code Country
kasr eini st,1 cairo 11796 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome more than 50% reduction in the narcotic requirement after intervention at two assessment intervals 6 hours after the procedure and four weeks later. 6 hours 4 weeks
Secondary Outcome patient activity after 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national cancer institute kasr eini st,1 cairo 12211 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national cancer institute , cairo university kasr eini st, 1 cairo 12211 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national cancer institute , cairo university kasr eini st, 1 cairo 12211 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ahmed abdallal elkhateeb 39 mosa ebn noseer st, naser city cairo 11471 Egypt
mohamed elramely 21 zizinia city, new cairo cairo 11835 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed adly mramely@hotmail.com 00201005125124 21 zizinia city, new cairo
City Postal code Country Position/Affiliation
cairo 11835 Egypt lecturer of anesthesia and pain management national cancer institute cairo university
Role Name Email Phone Street address
Public Enquiries Ahmed Mahmoud carnitin7@yahoo.com +201113308866 39 Mousa Ebn Nousir Street, 7th district, Nasr city
City Postal code Country Position/Affiliation
cairo 11471 Egypt
Role Name Email Phone Street address
Scientific Enquiries mohamed elramely mramely@hotmail.com 00201005125124 21 zizinia city, new cairo
City Postal code Country Position/Affiliation
cairo 11835 Egypt
Role Name Email Phone Street address
Scientific Enquiries mohamed elramely mramely@hotmail.com 00201005125124 21 zizinia city, new cairo
City Postal code Country Position/Affiliation
cairo 11835 Egypt lecturer of anesthesia and pain management, Cairo University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information