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.: PACTR202110874021535 Date of Approval: 11/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of blockade of thoracoabdominal nerves through perichondrial approach (TAPA) for postoperative analgesia in pediatric abdominal surgeries
Official scientific title Blockade of thoracoabdominal nerves through perichondrial approach (TAPA) versus Transversus Abdominis Plane Block(TAP) for postoperative analgesia in pediatric abdominal surgeries
Brief summary describing the background and objectives of the trial Blockage of thoracoabdominal nerves through perichondrial approach (TAPA) is a recently described novel regional anesthesia method that potentially provides an effective and extensive sensorial block of the thoracoabdominal region of the patients in the previous reports were adults, and there are no reports about the efficacy of TAPA in pediatric patients. Therefore, this study will be conducted to evaluate the efficacy of ultrasound-guided TAPA for postoperative analgesia in pediatric abdominal surgeries in comparison to TAP. The primary outcome will be whether there will be a need for analgesia in the first 24 hours. Secondary outcomes were the time in which the first analgesia will be required, FLACC scores, parent satisfaction, and hemodynamic changes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/08/2020
Actual trial start date 06/10/2020
Anticipated date of last follow up 05/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Blockade of thoracoabdominal nerves through perichondrial approach An injection of 0.5 mL/kg 0.2% bupivacaine will be applied in two directions - between the chondrium's upper surface and the external oblique and one between the chondrium's lower surface and the transversus abdominus muscle, both in the interfascial plane After induction of general anesthesia The ultrasound probe will be placed on the costal margin at the 9th–10th costal cartilage level in the sagittal plane and angled deeply to view the lower aspect of the chondrium centrally. A 22-gauge needle will be inserted using an in-plane technique. after making a negative aspiration test with 0.5mL normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 0.5 mL/kg 0.2% bupivacaine will be applied in two directions - between the chondrium's upper surface and the external oblique and one between the chondrium's lower surface and the transversus abdominus muscle, both in the interfascial plane. 50
Control Group Transversus Abdominis Plane Block An injection of 0.5 mL/kg 0.2% bupivacaine will be applied between the internal abdominal oblique and the transversus abdominis muscles. After induction of general anesthesia The ultrasound probe will be placed between the anterolateral abdominal wall and the iliac crest. The external abdominal oblique, internal abdominal oblique, and transversus abdominis muscles will be identified . A 22-gauge needle will be inserted using an in-plane technique. The needle will be directed from anterolateral to posteromedial toward the TAP after making a negative aspiration test with 0.5mL normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 0.5 mL/kg 0.2% bupivacaine will be applied between the internal abdominal oblique and the transversus abdominis muscles. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Aged between 1-7 years old. 2) Either sex. 3) American Society of Anesthesiology (ASA) I and II patients. 4) Scheduled for pediatric abdominal surgery. 1) Parental refusal of consent. 2) Hyperactive airway disease or respiratory diseases. 3) Children with developmental delays, mental or neurological disorders. 4) Bleeding or coagulation diathesis. 5) History of known sensitivity to the used anesthetics. 6) Infection or redness at the injection site. 7) Anatomic anomalies or liver diseases Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Year(s) 7 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 10/05/2020 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El Gohorria street mansoura 35546 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • The primary outcome is whether there is a need for analgesia in the first 24 hours. The first 24 hours
Secondary Outcome FLACC score Pain is assessed upon arrival to PACU, one, two, four, six, 12, 24 hours after surgery
Secondary Outcome • Satisfaction levels of the parents First 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ahmed Elaidy 2 El-Gomhouria Street mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospital 2 El-Gomhouria Street mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Amer Abd Allah Attia 2 El-Gomhouria Street mansoura 35516 Egypt
Eiad Ahmed Ramzy 2 El-Gomhouria Street mansoura 35516 Egypt
Nevert Adel Abd El Ghaffar 2 El-Gomhouria Street mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El Aidy a_m_elaidy88@yahoo.com +201099719913 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt Assistant lecturer of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Amer Attia amerattia@yahoo.com +201223982731 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Public Enquiries Eiad Ramzy Eiadramzy@yaho.com +201006445331 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university Role Name Email Phone Street
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results or a link to summary results will be shared within 12 months of the study completion date. Informed Consent Form Within 12 months of the study completion date We will provide individual participant data and share it through the PubMed indexed journal
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