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.: PACTR201502001009132 Date of Approval: 24/01/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dexmedetomidine decreases the required concentration of bupivacaine for ultrasound-guided transversus abdominis plane block in pediatric patients
Official scientific title Dexmedetomidine decreases the required concentration of bupivacaine for ultrasound-guided transversus abdominis plane block in pediatric patients: a randomized double-blind up-down dose-finding study
Brief summary describing the background and objectives of the trial Current knowledge on local anesthetic dosage for the ultrasound-guided transversus abdominis plane (TAP) block in pediatric patients is very limited. Dexmedetomidine (D) can prolong the duration of local anesthetics, but the effect of dexmedetomidine on the potency of bupivacaine for TAP block in pediatric patients has not been investigated. Methods This prospective randomized blinded study will be carried on 60ASA I &II patients aged 1-6years undergoing hernia repair or hydrocelectomy at El main university hospital after obtaining informed consent from parents of all participating subjects and obtaining approval of the Alexandria university ethics committee. Patients will be randomly assigned to one of the two groups: GroupB (TAP Bupivacaine), Group BD (Bupivacaine plus 2µg/kg dexmedetomidine). All children will receive a standardized anesthetic regimen. The primary endpoint of the study is the minimum local anesthetic concentration (MLAC). For each patient, the target concentration of TAP block bupivacaine will be determined using the modi¿ed Dixon¿s up-and-down method starting with 0.125% in each group, with 0.02% as a step size and the same total volume of 1 ml/kg. Increasing or decreasing the target concentration of TAP block will be determined by the response of the previous child in the same group. The response of each child will be observed for 60 s after the skin incision and evaluated as ¿successful¿ or ¿unsuccessful.¿ ¿Unsuccessful¿ is recorded when skin incision causes a change in hemodynamic parameters (heart rate and mean blood pressure) more than 20% of the preincision values. If the response is determined to be unsuccessful, the concentration of TAP block bupivacaine given to the next patient will be increased by 0.02%. The secondary endpoints are pain scores in the PACU measured by FLACC pain scores, time to analgesic requirement, the total number of additional analgesic requirements in 24 h, and adverse events.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,Surgery,ultrasound-guided transversus abdominis plane block in pediatric patients
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/03/2015
Actual trial start date
Anticipated date of last follow up 03/05/2015
Actual Last follow-up date 01/04/2015
Anticipated target sample size (number of participants) 60
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 randomisation using a randomisation table created by computer software program sealed opaque containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group BD (Bupivacaine plus 2µg/kg dexmedetomidine). once For each patient, the target concentration of TAP block bupivacaine will be determined using the modi¿ed Dixon¿s up-and-down method starting with 0.125% Bupivacaine in each group, with 0.02% as a step size and the same total volume of 1 ml/kg. Increasing or decreasing the target concentration of TAP block will be determined by the response of the previous child in the same group. The response of e 30 Dose Comparison
Control Group GroupB (TAP Bupivacaine) once For each patient, the target concentration of TAP block bupivacaine will be determined using the modi¿ed Dixon¿s up-and-down method starting with 0.125% Bupivacaine in each group, with 0.02% as a step size and the same total volume of 1 ml/kg. Increasing or decreasing the target concentration of TAP block will be determined by the response of the previous child in the same group. The response of e 30 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged between 1-6years ASA I &II undergoing hernia repair or hydrocelectomy local infection of the abdominal wall allergic to amide local anesthetics blood clotting disorders neurological, neuromuscular or psychiatric disorders severe renal, hepatic, respiratory, or cardiac diseases 1 Year(s) 6 Year(s) Male
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 25/02/2015 ethics committee faculty of medicine alexandria university
Ethics Committee Address
Street address City Postal code Country
17 champollion street alexandria 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary endpoint of the study is the minimum local anesthetic concentration (MLAC) The response of each child will be observed for 60 s after the skin incision
Secondary Outcome pain score measured by FLACC pain score every hour within 8 h after operation and then every 6 h as needed
Secondary Outcome postoperative sedation sedation were evaluated every hour within 8 h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Main university hospital el azerita square Alexandria 0000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
:Department of Anaesthesia and Surgical Intensive Care el azerita square alexandria 0000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor :Department of Anaesthesia and Surgical Intensive Care el azerita square alexandria 0000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
rehab abdel raouf el azerita square Alexandria 0000 Egypt
shahira el metainy el azerita square Alexandria 0000 Egypt
doaa abou alea el azerita square Alexandria 0000 Egypt
moataza abdel wahab High Institute of Public Health Alexandria 0000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator shahira el metainy shelmetainy@yahoo.com +201223527804 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000 Egypt Assistant Professor Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries doaa abou alia daboalia@yahoo.com 01227392473 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000 Egypt Assistant Professor Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries rehab abdel raoef trcium2002@yahoo.com +201001073703 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000 Egypt lecturer Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine
REPORTING
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