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.: PACTR201702001906427 Date of Approval: 03/12/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pain killing during radiofrequency ablation of liver tumors
Official scientific title Thoracic paravertebral block for analgesia during radiofrequency ablation of liver tumors
Brief summary describing the background and objectives of the trial Radiofrequency ablation of liver tumors is painful procedure that usually done with local anesthesia and sedation but the patient mostly feel marked discomfort and the radiologist become unsatisfied and general anesthesia may be required. so we try the use of special block to the nerves that supply the region of intervention (paravertebral block) to get more patient comfort and radiologist satisfaction
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,liver tumors,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2016
Actual trial start date 15/06/2016
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date 30/04/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 54
Recruitment status 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 simple randomisation using a randomisation table created by acomputer software program Sealed opaque envelopes Open-label(Masking Not Used) Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group thoracic paravertebral block 15 ml 0.5% bupivacaine 1 year injection into thoracic paravertebral space 30 Active-Treatment of Control Group
Control Group thoracic paravertebral block sham block normal saline 1 year injection into the parvertebral space 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients scheduled for radiofrequency ablation of liver tumors Patients with a Child-Pugh score more than B7, INR value more than 1.5, platelet count < 50000 and history for allergy to local anesthetics 40 Year(s) 70 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 15/12/2015 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Al- Geish st. faculty of medicine Tanta 31211 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome efficacy of thoracic paravertebral block in relieving pain during radiofrequency ablation of liver tumors 5 minutes 10 minutes 15 minutes 20 minutes 25 minutes
Secondary Outcome radiologist satisfaction just after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Al-Geish Tanta 31211 Egypt
Tanta oncology center Al-Geish Tanta 31211 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Hospital Al-Geish Tanta 31211 Egypt
Tanta oncology center Al-Geish Tanta 31211 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anesthesia Department Al-Geish Tanta 31211 Egypt Hospital
Secondary Sponsor faculty of medicine Tanta university Al-Geish Tanta 31211 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammad Ali Abdullah Al-Geish Tanta 31221 Egypt
Mohammad Mohyee Aboelyazid Mit Hebesh Tanta 31224 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammad Abdullah moh_aly_2005@hotmail.com +201099957971 Al-Geish
City Postal code Country Position/Affiliation
Tanta 31221 Egypt lecturer of anesthesiology
Role Name Email Phone Street address
Public Enquiries wessam aboelazm Nassar wessamnassar@gmail.com +201023800060 omar bin abdelziz
City Postal code Country Position/Affiliation
Tanta 31224 Egypt lecturer of anesthesiology
Role Name Email Phone Street address
Public Enquiries Mohammad Mohyee Aboelyazid mohd_yazed75@yahoo.com +201120014472 Mit Hebesh
City Postal code Country Position/Affiliation
Tanta 31224 Egypt lecturer of anesthesiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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