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.: PACTR201603001502110 Date of Approval: 03/03/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided bilateral paravertebral block for analgesia in elective cardiac surgery. Does it worth two punctures instead of one?
Official scientific title Ultrasound guided bilateral paravertebral block for analgesia in elective cardiac surgery.
Brief summary describing the background and objectives of the trial The aim of this study is to evaluate the efficacy of U.S. guided bilateral thorathic paravertebral block as a method of pain control in conventional cardiac surgery patients in comparison to midline Thorathic epidural block (primary end point).The duration of mechanical ventilation, and ICU stay.(secondary end point)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Cardiology,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/03/2016
Actual trial start date
Anticipated date of last follow up 15/09/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Faculty of medicine ethical committee approval 30775/02/16
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 stratified blocked randomization sealed closed envelop Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultra sound guided bilateral paravertebral block 8 ml of 0.25% bubivacain continuously injected in each catheter from patient entery to OR till 48h. after operation at the level of T6, using U/S guidence two catheters will be threaded into the paravertebral space 75 Active-Treatment of Control Group
Control Group Epidural group 8 ml/h 0.25% bubivacaine in the catheter after Induction until 48h post extubation Thoracic epidural block at the level of T6 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients scheduled for electivecardiac surgery, will be included in this study. ¿Patients' refusal, ¿Bleeding disorders or coagulopathy, ¿Allergy to local anesthetics, ¿Infection at the injection site, ¿Anatomic deformities of the spine, ¿Pregnancy or Breast feeding, ¿Severe organ insufficiency (renal orliver dysfunction). ¿Pre-existing neurological deficits, ¿Reoperation within 24h from the initial procedure. 18 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 16/02/2016 Research ethical committee, faculty of medicine, Tanta university, Egypt.
Ethics Committee Address
Street address City Postal code Country
Medical campus, El geish street, Tanta Faculty of medicine, 4th floor. Tanta 31111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain control in conventional cardiac surgery patients immediate post operative post extubation 12h post extubation 24h post extubation
Secondary Outcome The duration of mechanical ventilation after enterance to ICU till extubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospitals medical campus, el geish street Tanta 31111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self fund by researchers Tanta 31111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor hatem abdel fatah Ibrahim el shora El fateh street, El Goumla Square Tanta 31111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
hatem Abdel Fatah Ibrahim El shora el fateh street, el goumla square Tanta 31111 Egypt
Ahmed Adel Abdel fatah El beleehy Abou Baker el sadek street Tanta 31111 Egypt
AMR ARAFAT Tanta 31111 Egypt
AMR MAHMOUD
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hatem el shora hatem.elshoura@med.tanta.edu.eg +201093878990 El fateh street, El Goumla Square
City Postal code Country Position/Affiliation
Tanta 31111 Egypt lecturer of anesthesia and surgical intensive care, Tanta University Hospitals
Role Name Email Phone Street address
Public Enquiries Ahmed El beleehy ahmedelbeleehy@gmail.com +2 01022090987 Abou baker el sadek
City Postal code Country Position/Affiliation
Tanta 31111 Egypt lecturer of anesthesia and surgical intensive care, Tanta University Hospitals
Role Name Email Phone Street address
Scientific Enquiries Ahmed El beleehy ahmedelbeleehy@gmail.com +201022090987 Abou baker el sadek
City Postal code Country Position/Affiliation
Tanta 31111 Egypt lecturer of anesthesia and surgical intensive care, Tanta University Hospitals
REPORTING
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Result URL Hyperlinks Link To Protocol
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