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.: PACTR201705002296409 Date of Approval: 13/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided thoracic paravertebral block versus subcostal transversus abdominis plane block
Official scientific title Ultrasound guided thoracic paravertebral block versus subcostal transversus abdominis plane block for postoperative pain relief in pediatric patients with beta thalassemia major undergoing splenectomy. A prospective randomized study
Brief summary describing the background and objectives of the trial Open splenectomy with subcostal incision is associated with severe postoperative pain. Several studies has demonstrated the efficacy of TAP block in providing sufficient and long lasting postoperative pain relief after abdominal surgery. Similarly, thoracic paravertebral block (PVB) has been demonstrated to provide effective for anesthesia and analgesia in patients undergoing a wide variety of abdominal surgical procedures by blocking sensory innervation of the abdominal wall.The objective of this study is to compare between ultrasound guided thoracic paravertebral block and subcostal transverses abdominis plane block in pediatric patients with beta thalassemia major as regards quality of postoperative analgesia, onset of 1st rescue analgesic requirement and incidence of complications
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial compare between ultrasound guided thoracic paravertebral block and subcostal transverses abdominis plane block
Anticipated trial start date 14/05/2017
Actual trial start date
Anticipated date of last follow up 14/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Not yet 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 randomisation using a randomisation table from a statistics book Sealed opaque envelopes 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 sham paravertebral block and sham subcostal transversus abdominis plane block once once ultrasound guidedsham paravertebral block and sham subcostal transversus abdominis plane block 30
Experimental Group paravertebral block once once receive ipsilateral ultrasound-guided thoracic paravertebral block with 0.5ml/kg bupivacaine 0.25% and sham subcostal transversus abdominis plane block after induction of general anesthesia 30
Experimental Group ¿ Transversus abdominis plane block once once ipsilateral ultrasound-guided subcostal transversus abdominis plane block with 0.5ml/kg bupivacaine 0.25% and sham Paravertebral block after induction of general anesthesia 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
beta thalassemia major patients ASA physical status I- III undergoing elective open splenectomy via subcostal incision Refusal of regional block Bleeding disorders Skin lesions, wounds or infection at the site of proposed needle insertion Developmental mental delay (unable to be assessed for pain score) , psychiatric illness or neurological deficits Renal dysfunction, cardiac patients 6Known hypersensitivity to relevant drugs Peritonitis or septicemia Patients with ventriculo-peritoneal shunt in situ will also be excluded 3 Year(s) 10 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 23/04/2017 faculty of medicine- tanta university
Ethics Committee Address
Street address City Postal code Country
el geish st tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome onset of first analgesic requirement at cheops scoremore than6
Secondary Outcome postoperative cheops pain scors on admission to pacu 2h 4h 8h 12h 24h
Secondary Outcome postoperative fentanyl consumption 24h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital el geish st tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university hospital el geish st tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital el geish st tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mona blough el mourad el geish st tanta 31527 Egypt
mohamed mohi abu elyazed el geish st tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mona el mourad monamorad80@gmail.com 0403418324 el geish st
City Postal code Country Position/Affiliation
tanta 31527 Egypt lecturer of anesthesia-faculty of medicine- tanta university
Role Name Email Phone Street address
Public Enquiries mona el mourad monamorad80@gmail.com 0403418324 el geish st
City Postal code Country Position/Affiliation
tanta 31527 Egypt lecturer of anesthesia-faculty of medicine- tanta university
Role Name Email Phone Street address
Scientific Enquiries mohamed abu elyazed mohd_yazed75@yahoo.com 0403418324 el geish st
City Postal code Country Position/Affiliation
tanta 31527 Egypt lecturer of anesthesia-faculty of medicine- 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