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.: PACTR201908568919626 Date of Registration: 29/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title controlled study between erector spinea plane block versus paravertebral nerve block in neonates undergoing tracheo-esophageal fistula repair
Official scientific title A comparative randomized controlled study between ultrasound-guided erector spinea plane block versus paravertebral nerve block for narcotic consumption in neonates undergoing tracheo-esophageal fistula repair
Brief summary describing the background and objectives of the trial The primary aim is to compare ultrasound guided erector spinae plane block vs paravertebral nerve block for narcotic and anesthetic consumption in neonates undergoing tracheo-esophageal fistula repair. The secondary aim is to measure hemodynamic changes, postoperative analgesic consumption, and incidence of complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Neonatal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/07/2019
Actual trial start date 01/07/2019
Anticipated date of last follow up 01/07/2021
Actual Last follow-up date 01/07/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group erector spinae plane block group 2–3 mg/kg bupivacaine 0.25% with epinephrine 1: 200 000 (maximum total volume 5 ml). Just after receiving general anesthesia for 24 h postoperative Ultrasound guided erector spinae plane block 20
Control Group Paravertebral block group 2–3 mg/kg bupivacaine 0.25% with epinephrine 1: 200 000 (maximum total volume 5 ml). Just after receiving generai anesthesia for 24 h postoperative Ultrasound guided Paravertebral block group 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients selected will be of both sexes aged 1 to 30 days scheduled for tracheo-esophageal fistula repair surgery. Patients known to be allergic to any of the study drugs, known or suspected coagulopathy or recent use of anticoagulant/antiplatelet drugs, any signs of infection, congenital abnormalities of spine and meninges, empyema. New born: 0 Day-1 Month 1 Day(s) 30 Day(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 01/07/2019 Menoufia University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
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 01/07/2019 Benha Children Hospital
Ethics Committee Address
Street address City Postal code Country
Banha Sports Stadium Street - Al Qalyubia Benha 13511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary aim is to compare ultrasound guided erector spinae plane block vs paravertebral nerve block for narcotic and anesthetic consumption in neonates undergoing tracheo-esophageal fistula repair. 1- Heart rate, mean arterial blood pressure, and arterial oxygen saturation will be measured continuously
Secondary Outcome The secondary aim is to measure hemodynamic changes, postoperative analgesic consumption, and incidence of complications. 1- Heart rate, mean arterial blood pressure, and arterial oxygen saturation will be measured continuously
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd -Elghafar street Shibin Elkom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine 25 Yasin Abd -Elghafar street Shibin Elkom Egypt
Benha Children Hospital Banha, Al Qalyubia Benha 13511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd -Elghafar street Shibin Elkom 002048 Egypt University
Secondary Sponsor Banha pediatric Hospital Estad Benha El Rayadi St Banha Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
heba reffat mohammed el sharaky al remali - quewesna quewesna Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator heba el sharaky heba.reffat@yahoo.com 00201008799394 el remali
City Postal code Country Position/Affiliation
quewesna Egypt Assistant lecturer of anesthesia in Menoufiya University.
Role Name Email Phone Street address
Principal Investigator Nadia Mohee Eldin Bahgat dr_nmbahgat@med.menofia.edu.eg 00201009558238 Mohammed Husseini street
City Postal code Country Position/Affiliation
Shibin Elkom Egypt Lecturer of anesthesia in Menoufia University.
Role Name Email Phone Street address
Public Enquiries Hatem Bhagat hatem_wafa@hotmail.com 002701155497711 25 Yasin Abd-Elghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Lecturer of anesthesia.
Role Name Email Phone Street address
Public Enquiries Ashraf Eskander ameskandr@yahoo.com 00201001960697 25 Yasin Abd-Elghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant professor of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Khaled Abu El Einein mahmoudk16@yahoo.com 00201015406676 Al Bahari street
City Postal code Country Position/Affiliation
Alexandria 002003 Egypt Professor of anesthesia.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes demographic data as age, sex, weight, duration of surgery vital sign measurments; heart rate, blood pressure,O2 saturation, intraoperative isoflurane and opoid consumption, time to first need of analgesia, postoperative pain score. complication as bradycardia, hypotension, hypoxia, hypothermia. Informed Consent Form,Statistical Analysis Plan,Study Protocol june 2019 to july 2021 caudal epidural. neonates. transesophageal fistula repair
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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