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.: PACTR202110701059005 Date of Approval: 29/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF THORACIC EPIDURAL ANAESTHESIA VIA CAUDAL APPROACH IN TRACHEOESOPHAGEAL FISTULA REPAIR
Official scientific title EFFECT OF ULTRASOUND GUIDED THORACIC EPIDURAL ANAESTHESIA VIA CAUDAL APPROACH ON POSTOPERATIVE PAIN AND STRESS IN NEONATES UNDERGOING TRACHEOESOPHAGEAL FISTULA REPAIR
Brief summary describing the background and objectives of the trial Is to compare the effect of using ultrasound guided thoracic epidural via caudal approach versus systemic analgesia on postoperative pain & stress response post-thoracotomy in neonates undergoing tracheo-osophageal fistula.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 20/11/2021
Actual trial start date
Anticipated date of last follow up 30/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Active, not 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Caudal epidural Initial bolus 0.75 ml/kg of 0.125%levo- bupivacaine will be administered after negative aspiration for cerebrospinal fluid and blood with continuous ECG monitoring. For insertion of caudal epidural catheter; Preparation of an appropriate sized ultrasound linear probe. Under complete aseptic sterile technique with drapes, US cover and sterile gel neonate will be placed in the left lateral position with knees, hips, and spine flexion. Measure the length from caudal space to the desired level of epidural blockade to achieve a well-functioning epidural block, the tip of the epidural catheter is situated at intra-spinal level that corresponds to the dermatomal center of the surgical procedure. Caudal epidural space will be located using 20-gauge Touhy needle (Perifix® ONE Paed; B. Braun, Germany) with “loss of resistance” technique and 24-gauge epidural catheter will be placed in the epidural space. Under ultrasound guidance 3 ml of 0.9% normal saline will be injected to widen epidural space and facilitate threading of epidural catheter. 24-gauge epidural catheter will be introduced through caudally inserted 20-gauge Touhy needle to the required level of epidural block under vision using ultrasound. Initial bolus 0.75 ml/kg of 0.125%levo- bupivacaine will be administered after negative aspiration for cerebrospinal fluid and blood with continuous ECG monitoring. Epidural catheter will be secured by looping the catheter at the entry site and covering with a clean plastic dressing, then routed over the shoulder and fixed to the skin with micropore tape 45
Control Group Intravenous analgesia 2 µg/kg)/IV and paracetamol (10 mg/kg)/IV for intra-operative analgesia. Will receive fentanyl (2 µg/kg)/IV and paracetamol (10 mg/kg)/IV for intra-operative analgesia. 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria • Age: neonates (0-30 days). • Scheduled for tracheoosophageal fistula repair. Exclusion criteria • Any contraindication to epidural blockade. • Presence of Congenital heart diseases. • Mechanically ventilated neonates. • Prematurity. • Low body weight (<2.4 kg). • Accidental removal of epidural catheter <24 h postoperatively. • Vertebral anomalies. 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 15/04/2021 Ethics Committee Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion street, Elmessalah, ALexandria, Egypt Alexandria 21669 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain & stress response It will be assessed every 30 minutes in the first 2 hours then every 2 hour for the next 24 hours
Secondary Outcome length of stay (LOS), supplemental analgesic requirements, and the incidence of adverse respiratory events t will be assessed every 30 minutes in the first 2 hours then every 2 hour for the next 24 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Anesthesia and surgical ICU Faculty of medicine Alexandria University 17 Champollion street, Elmessalah, Alexandria, Egypt Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Alexandria University 17 Champollion street, Elmessalah, Alexandria, Egypt Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Sherif Ahmed Fouad Shabaan sh3bola@hotmail.com 00201062691955 Building 1 Hedaya Street, Gleem, Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant lecturer of Anesthesia and surgical ICU Faculty of medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Ibrahim Mohamed drmohamedima@gmail.com 00201222710521 17 champollion street, Elmessalah, Alexandria
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Anesthesia and Surgical ICU
Role Name Email Phone Street address
Public Enquiries Yasser Mohamed Othman yasseralx@hotmail.com 00201006357996 17 Champollion street, Elmessalah, Alexandria Egypt
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Professor in Anesthesia and Surgical Intensive Care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes detailed individual participants data are available if it is requested after their consent. Clinical Study Report,Statistical Analysis Plan,Study Protocol within 2 years controlled access
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