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.: PACTR201702001987109 Date of Approval: 19/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ultrasound guided rectus sheath block for post operative pain in pediatric
Official scientific title comparative study between caudal block and ultra-sound guided rectus sheath block for post operative analgesia in pediatric patients undergoing umbilical hernia repair.
Brief summary describing the background and objectives of the trial 60 patients undergoing elective umbilical hernia repair were allocated randomly into two groups: U/S-guided rectus sheath block (RSB) (group A) and caudal block (CB) (group B). All patients received the same general anesthetic technique. In A group, bilateral U/S-guided RSB was performed using 0.25%bupivacaine 0.25 ml/kg. In B group, CB was performed using 0.25% bupivacaine 1 ml/kg. Postoperative analgesia using a modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and total amount of Post-operative paracetamol requirement as rescue analgesia were recorded.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCB CB
Disease(s) or condition(s) being studied Surgery,US guided RCB and role as post operative analgesia in children
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 13/06/2015
Actual trial start date 13/06/2015
Anticipated date of last follow up 11/06/2016
Actual Last follow-up date 01/06/2016
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 60
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 sealed envelopes a blinded nurse read the number contained in the sealed envelopes and made group assignement Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised sealed envelopes a blinded nurse read the number contained in the sealed envelopes and made group assignement Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group caudal block 0.25% bupivacaine 1 ml/ kg once regional block 30 Active-Treatment of Control Group
Experimental Group ultrasound guided rectus sheath block 0.25% bupivacaine 0.25 ml/kg once regional block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male and female patients aged 1 - 6 years old scheduled for umbilical hernia repair. ASA physical status I or II Parents refusal Upper air way infection 2 weeks ago or less. ASA physical status 3 or more. Patient aged above 6 years or below 1 year. Fever. Allergy to bupivacaine. Bleeding and coagulation disorders. Patient with neurological problems, specially affecting lower limb 1 Year(s) 6 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 11/04/2015 Tanya univerisity hospital
Ethics Committee Address
Street address City Postal code Country
El Geish street Tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measure pain score in both group postoperative Postoperative analgesia was measured using a modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) at 30 minute, 1 hr, 2hrs then every 2 hours up to 12 hours and then every 4 hours up to 24 hours.
Secondary Outcome recsue analgesia post operative amount of rescue analgesia was measured and onset of first rescue analgesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta univerisity hospital EL geish street Tanta 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta univerisity hospital EL geish street Tanta 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
amgad shaaban EL geish street Tanta 31257 Egypt
mona blough elmourad EL geish street tanta 31257 Egypt
ahmad said elgebally EL geish street tanta 31257 Egypt
mohammad okab EL geish street tanta 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amgad shaaban amgadshaaaban@gmail.com 01096377883 el geish street
City Postal code Country Position/Affiliation
tanta 31257 Egypt doctor , Tanta university hospitals
Role Name Email Phone Street address
Public Enquiries mona blough elmourad monamorad80@gmail.com 01019425213 el geish street
City Postal code Country Position/Affiliation
tanta 31257 Egypt lecturer of anesthesia and intensive care , Tanta university
Role Name Email Phone Street address
Public Enquiries ahmed elgebally elgebaly_13@hotmail.com 01111109854 el geish street
City Postal code Country Position/Affiliation
Tanta 31257 Egypt professor of anesthesia and intensive care , Tanta university
Role Name Email Phone Street address
Scientific Enquiries mohamed okab mohamed.okab@med.tanta.edu.eg 01222818703 elnhaas street
City Postal code Country Position/Affiliation
Tanta 31257 Egypt professor of anesthesia and intensive care , Tanta university
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information