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.: PACTR201604001562352 Date of Approval: 02/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title TAP block and neuroendocrine stress response
Official scientific title The effect of ultrasound guided transversus abdominis plane ( TAP ) block on postoperative analgesia and neuroendocrine stress response in pediatric patients undergoing elective open inguinal hernia repair
Brief summary describing the background and objectives of the trial Surgical stress is defined as the impact exerted on the human body by a surgical procedure. Surgical trauma causes a surge of physiological and immunological reactions for preservation of homeostasis and survival. Stress responses associated with surgical trauma may cause subtle changes in hormonal secretion, initiated by neuronal activation of the hypothalamic-pituitary-adrenal axis. Enhanced plasma cortisol level and suppressed anabolic hormones, such as insulin, may have deleterious effects during the perioperative period. Anterior abdominal wall incisions cause considerable postoperative pain, an important variable in the surgical stress response and outcome. The TAP is a neurofascial plane in the anterior abdominal wall lying between internal oblique and transversus abdominis. The aim of the study is to assess the effect of the ultrasound guided transversus abdominis plane ( TAP ) block on postoperative analgesia and neuro-endocrine stress response in pediatric patients undergoing elective open inguinal hernia repair.
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: Devices
Anticipated trial start date 01/07/2015
Actual trial start date 01/08/2015
Anticipated date of last follow up 01/01/2016
Actual Last follow-up date 01/02/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
30226/04/15 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality assurance unit
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 Permuted block randomi 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 Ganeral anesthesia only 30
Experimental Group TAP group 0.4 ml/kg bupivacaine 0.25%. Total dose not exceeding 2 mg/kg and total volume not more than 20 ml Once Ultrasound guided TAP block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 3 - 10 years Either gender ASA I - II Elective open inguinal hernia repair Sepsis Multiorgan dysfunction syndrome Cardiac disorder Renal disorder Immunologic disorder Metabolic abnormality Patients with an oxygen requirement Contraindication for TAP block as surgical scar or distorted anatomy at site of injection Known hypersensitivity to studied drugs 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 15/04/2015 Research ethics committee, quality assurance unit, Faculty of Medicine, Tanta University
Ethics Committee Address
Street address City Postal code Country
Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome CHEOPS and OPS scores 0 immediate after transport to PACU 2 hr 4 hr 8 hr 12 hr 24 hr postoperative
Primary Outcome Blood glucose Before induction 30 min after surgical incision 30 min after end of surgery
Primary Outcome Serum cortisol Before induction 30 min after surgical incision 30 min after end of surgery
Secondary Outcome Rescue analgesia Time of first request Total dose/ 24 hr
Secondary Outcome Complications as nausea, vomiting, infection or hematoma Any time if occured
Secondary Outcome Patient satisfaction Once after 24 hr
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals 10 Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, Tanta University Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of anesthesia and surgical ICU 10 Algeish street Tanta Egypt Hospital
Primary Sponsor Faculty of Medicine, Tanta University 10 Algeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
Mohammed Ali Abdallah 12 Stad street Tanta Egypt
Geehan Morsy 7 Tharwat street Tanta Egypt
Mohammed Mohey Aldeen 22Stad street Tanta
Mohammed Mohey Aldeen 22Stad street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb Square, Alsokkary building, Flat 10
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt Lecturer of anesthesia and surgical ICU, Faculty of Medicine, Tanta University
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb Square
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt Lecturer of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Geehan Morsy gehan2552011@gmail.com 01287466651 7 Tharwat street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesia and ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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