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.: PACTR202111605483298 Date of Registration: 12/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of bilateral PECS II block in postoperative analgesia for ultrafast track pediatric cardiac anesthesia
Official scientific title Efficacy of bilateral PECS II block in postoperative analgesia for ultrafast track pediatric cardiac anesthesia
Brief summary describing the background and objectives of the trial This study aims to evaluate the efficacy of PECS II block analgesic effects to control post-sternotomy pain in the pediatric population in ultrafast track cardiac surgery.
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 01/10/2021
Actual trial start date 30/10/2021
Anticipated date of last follow up 01/01/2022
Actual Last follow-up date 18/12/2021
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 45
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 PECS II block 0.25 ml/kg bupivacaine 0.25% on each side once Patients will receive PECS II block as ultrasound probe will be placed at the midclavicular level oriented inferolateral to locate the axillary artery and vein and then moved laterally toward the axilla until pectoralis major, pectoralis minor, and serratus anterior muscles were identified at the level of the fourth rib. The needle was inserted in-plane concerning the ultrasound probe. A volume of 0.5ml/kg of bupivacaine 0.25% will be deposited in the fascial plane between the pectoralis minor and serratus anterior muscle. 20
Control Group on block control nil nil This group will recieve standard care of perioperative analgesia in the form of intraoperative fentanyl. and postoperative paracetamol and fentanyl in cases of breakthrough pain 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All pediatric patients presented for open-heart surgery utilizing median sternotomy. • ASA physical status 2-3 • Sex (males and females) • Age 1-5 years. • Hypersensitivity to local anesthetic. • Parental refusal. • Surgeon refusal. • Infection at the site of injection. • Preoperative critically ill child. • Any coagulopathy. • Non-sternotomy approaches, e.g., thoracotomy. • Postoperative Hemodynamic instability or high doses of inotropic support. Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 5 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 30/10/2021 Ain Shams University Faculty of Medicine Research Ethics Committee REC FWA 00017585
Ethics Committee Address
Street address City Postal code Country
38 Abbasyia sq cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain score utilizing Modified Objective Pain Score (MOPS) immediately after extubation. utilizing Crying Movement Agitation Posture Verbal The minimum score is 0 and the maximum is 10; the higher the score, the greater the pain experience for the child. six hour after extubation
Secondary Outcome MOPS Postextubationin time Intervals up to 12 Hours every 2 hours for first 6 hours then at 12 hours
Secondary Outcome PAED score on arrival to ICU. once on arrival to ICU
Secondary Outcome Total fentanyl consumption in the first 24 hours first 24 hours
Secondary Outcome Time of the first rescue analgesia (rescue analgesia will be given in case of breakthrough pain MOPS ≥ 4 inform of 0.5 mcg/kg fentanyl) hours till first call for analgesia
Secondary Outcome ICU stay days of ICU stay
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospital 392 ramses street cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Farouk kamal Eldin 137 Mamdouh salem nasr city cairo 11599 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Farouk Kamal 137 mamdouh salem street cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Farouk Kamal Eldin dr.faroukkamal@med.asu.edu.eg +201066241179 137 mamdouh salem st
City Postal code Country Position/Affiliation
cairo 11759 Egypt lecturer of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Farouk Kamal Eldin dr.faroukkamal@med.asu.edu.eg +201066241179 137 Mamdouh Salem
City Postal code Country Position/Affiliation
nasr city cairo 11599 Egypt lecturer of anesthesia faculty of medicine ain shams university
Role Name Email Phone Street address
Public Enquiries Amr Hafez amr_foud@med.asu.edu.eg +201225674370 5th area street 8
City Postal code Country Position/Affiliation
fifth settelment 11835 Egypt lecturer of anesthesia faculty of medcine ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes I will give all IPD that underly the results of publication Informed Consent Form,Statistical Analysis Plan,Study Protocol starting six month after publication controlled access after request for principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.tandfonline.com/doi/full/10.1080/11101849.2022.2043523 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