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.: PACTR202209499712392 Date of Approval: 05/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Peritibial infiltration block for tibial osteotomy.
Official scientific title Peritibial fascial infiltration block for postoperative analgesia in pediatric patients scheduled for tibial osteotomy. A prospective randomized trial
Brief summary describing the background and objectives of the trial Ultrasound-guided interfascial plane blocks are an important development in regional anesthesia practice and provide a new method to transmit local anesthetic to different anatomical areas. The aim of this study is to assess the efficacy of peritibial fascial plane block to achieve analgesia after tibial osteotomy in children.
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 Treatment: Other
Anticipated trial start date 17/09/2022
Actual trial start date
Anticipated date of last follow up 01/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group peritibial fascial infiltration block once once Patients will receive general anesthesia combined with ultrasound- guided peritibial fascial infiltration block 25
Control Group general anesthesia once once patients will receive general anesthesia alone 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-pediatric patients -aged 2- 7 years -of either gender -ASA I-II -undergoing elective surgical tibial osteotomy - Parental refusal - Allergy to the study drugs - Any contraindication to regional anesthesia e.g. infection at injection site or coagulopathy. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 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 08/08/2022 Research Ethics Committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
Elgeish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome total postoperative analgesic requirement once
Secondary Outcome pain score up to 24 h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Elgeish Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mona El Mourad Elgeish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University Elgeish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Blough El Mourad Elgeish Tanta 31527 Egypt
Gehan Morsy Eid Elgeish Tanta 31527 Egypt
Mohamed Shebl Abdelghany Elgeish Tanta 31527 Egypt
Aliaa Muhammad Belal Elgeish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona El Mourad monamorad80@gmail.com 0020403317928 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor of Anesthesia Surgical Intensive Care and Pain Medicine Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Gehan Eid gehan2552011@gmail.com 0020403317928 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor of Anesthesia Surgical Intensive Care and Pain Medicine Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdelghany shebl7000@gmail.com 0020403317928 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor of Anesthesia Surgical Intensive Care and PainMedicine Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in article, after deidentification (text, tables, figure, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Researchers who provide a methodologically sound proposal
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