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.: PACTR201904578316891 Date of Approval: 15/04/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Caudal epidural with thoracic level for transesophageal fistula (TOF) repair surgery in neonates
Official scientific title Single shot Caudal epidural with thoracic level for transesophageal fistula repair surgery in neonates, a double-blinded, randomized controlled trial.
Brief summary describing the background and objectives of the trial Caudal epidural injection in neonate can achieve good analgesia reach even the thoracic level according to the volume of local anesthetic injected. It helps decreasing opioid and isoflurane consumption with more hemodynamic stability intraoperative and extended analgesia postoperative. We try to use this simple effective and safe technique for TOF repair surgery in neonates and comparing it with non-caudal general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Caudal epidural with thoracic level for controlling thoracotomy pain in neonate.
Anticipated trial start date 01/05/2018
Actual trial start date 01/05/2018
Anticipated date of last follow up 01/01/2021
Actual Last follow-up date 01/01/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group caudal group C single shot caudal epidural after induction of general anesthesia. the dose of injected local anesthetic is 2.5-3 mg/kg bupivacaine diluted in saline to reach 1.7ml/kg was injected with epinephrine 1\200000 and in addition to 0.1 mg/kg dexamethasone. once after induction of general anesthesia. The neonate was then carefully placed and supported in right lateral position with the knees, hips and the lumbar spine flexed to receive single shot caudal block after complete aseptic condition use sacral hiatus as an access to reach epidural space. A 22G caudal needle was inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone is contacted to be parallel to the canal. A subjective feeling of loss of resistance suggests piercing the Sacro Coccygeal Ligament. After confirming negative aspiration for blood and/ or cerebrospinal fluid, the local anesthetic is injected. 20
Control Group non caudal Group NC received only general anesthesia no caudal block, received only general anesthesia all cases had an inhalational induction, with sevoflurane, to be intubated orally under deep inhalational anesthesia and if needed with the aid of a neuromuscular blocker. The endo-tracheal tube place was confirmed using fiberoptic bronchoscopy to inshore bypassing the fistula site. If the size of tube was 3 or less the fiberoptic cannot pass through it so we insert tube deeply in right main bronchus then slowly withdrawal with osculation until equality confirmation. Some cases were already intubated in ICU on mechanical ventilation due to lunge condition. Regarding vascular access, all cases had at least one peripheral i.v. line preoperatively in ICU. To supplement the i.v. access after induction, one further peripheral line was inserted. Some cases needed to have an internal jugular or femoral as central venous line. All cases had an arterial line preductal to monitor arterial blood pressure and blood gas sampling. Patient turned in a semi-prone position, their right side elevated 45 and the right arm placed above their head. In all cases anesthesia was maintained throughout the procedure with 0.6-1% isoflurane anesthetic agent. The need for rescue fentanyl 0.5 microgram kg-1 was considered if an increase in SBP or HR of more than 15% compared with baseline values obtained just before the surgical incision, Fluid therapy was cautiously restricted during and after surgery to avoid high liability to pulmonary edema. During surgery, patients received warmed lactated Ringer’s solution 6 ml·kg−1·h−1 for maintenance, replacement of third space and blood losses, a glucose 10% solution was infused at a rate of 1–2 ml·kg−1·h−1 in a separate line to maintained blood glucose level. red blood cells were given to replace blood losses when hematocrit dropped below 30%.Intermittent positive pressure ventilation was delivered. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged 1 to 30 days, both sexes, scheduled for transesophageal 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. patient's relatives refuse the caudal procedure. New born: 0 Day-1 Month 0 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 01/05/2018 Faculty of Medicine anesthesia department
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemodynamic stability, Heart rate, systolic blood pressure, O2 saturation, respiratory rate and temperature Heart rate, systolic blood pressure, O2 saturation, respiratory rate and temperature were recorded every 5min all over the surgery.
Primary Outcome Total intraoperative inhalational anesthetic and fentanyl consumption inhalational anesthetic and fentanyl consumption were recorded every 5min allover the operation
Secondary Outcome Postoperative pain scores . were recorded at 1, 6, 12, 18, and 24 h postoperative.
Secondary Outcome Total postoperative 24 h fentanyl requirements and time to first postoperative rescue analgesia summation of total postoperative 24 h fentanyl requirements and time to first postoperative rescue analgesia was recorded
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Anesthesia and Intensive Care Department Faculty of Medicine Menoufia University 25 Yasin Abd-Elghafar street. Shibin Elkom 002048 Egypt
Banha child Hospital Dr Fouad Mohey El Din street. Banha 003056 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nadia mohee Eldin Bahgat. Mohammed Husseini street Shibin Elkom 002048 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
COLLABORATORS
Name Street address City Postal code Country
Dr Nadia Mohee Eldin Bahgat Mohammed Husseini street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nadia Mohee Eldin Bahgat dr_nmbahgat@yahoo.com 01009558238 Mohammed Husseini street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Lecturer of anesthesia and intensive Care Faculty of Medicine Menoufia University
Role Name Email Phone Street address
Public Enquiries Alaa Aiad alaa222aiad@gmail.com 01012343971 25 Yasin Abd-Elghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Lecturer of anesthesia and intensive Care Faculty of Medicine Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Elham Elfeky elhamelfeky@yahoo.com 01222913227 Elnaser street
City Postal code Country Position/Affiliation
Menof 002487 Egypt Assistant professor of anesthesia and intensive Care Faculty of Medicine Menoufia University
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 measurement: heart rat, systolic blood pressure, O2 saturation, intraoperative isoflurane and opioid consumption, time to first need of analgesia, postoperative pain score, indecent of complication as bradycardia, hypotension, hypoxia, hypothermia. Informed Consent Form,Statistical Analysis Plan,Study Protocol June 2019 to October 2021 caudal epidural, neonates, trans-esophageal 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