Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201606001632982 Date of Approval: 13/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexamethasone versus neostigmine as an adjuvant to bupivcaine 0.25% for caudal analgesia in children undergoing open inguinal hernia repair
Official scientific title Dexamethasone versus neostigmine as an adjuvant to bupivcaine 0.25% for caudal analgesia in children undergoing open inguinal hernia repair
Brief summary describing the background and objectives of the trial Because of its safety and the ease of its access, caudal epidural block is commonly used for intra-operative and postoperative analgesia in pediatric patients undergoing infra-umbilical surgery (1). The main disadvantage of caudal analgesia is the short duration of action after a single injection (2). Several adjuvant such as fentanyl (3) , ketamine (4), clonidine (5,6), tramadol (7), midazolam ( 8 ) and dexmedetomidine (9) can be added to the local anesthetics to improve the quality and the duration of the caudal block. Neostigmine is enzyme cholinesterase inhibitor that causing an increase of the acetylcholine concentration(10). Neostigmine has been used as an adjuvant to local anesthetics for caudal epidural analgesia (11,12 ). Dexamethasone has strong anti¿inflammatory effects, started to be investigated for its analgesic efficacy. Epidurally administered dexamethasone could reduce the incidence and severity of postoperative pain in adults and in children (13, 14). So the primary outcome of this study will be to compare the duration of postoperative analgesia of caudal block when dexamethasone and neostigmine will be added to bupivacaine 0.25% in children. Secondary outcomes will be the hemodynamic stability and postoperative complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied congenital inguinal hernia in children,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/03/2016
Actual trial start date 01/04/2016
Anticipated date of last follow up 31/05/2016
Actual Last follow-up date 30/09/2016
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants) 105
Recruitment status Completed
Publication URL 30858/04/16
Secondary Ids Issuing authority/Trial register
research ethics committee faculty of medicine
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 radomisation table created by a computer software program ¿Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group II ( bupivacaine ¿dexamethasone group): Patients of this group will receive intraoperative caudal analgesia by using bupivacaine 0.25% (0.75ml/kg) with dexamethasone 0.1mg/kg in 1ml normal saline the intervention will be started after induction of anesthesia and continued after end of surgery On arrival to the operating room, routine monitoring including electocardiography, non invasive arterial blood pressure and pulse oximetery. Inhalational induction with 6-8% sevoflurane via face mask will be done in all patients. 22 G intravenous canula will be inserted after patient become unconscious. Endotracheal intubation will be done after giving atracurium 0.5 mg/kg. Patient will be c 35
Control Group Group I (bupivacaine group): Patients of this group will receive intra-operative caudal analgesia by using bupivacaine 0.25% (0.75ml/kg) with 1ml normal saline. the intervention will be started after induction of anesthesia and continued after end of surgery On arrival to the operating room, routine monitoring including electocardiography, non invasive arterial blood pressure and pulse oximetery. Inhalational induction with 6-8% sevoflurane via face mask will be done in all patients. 22 G intravenous canula will be inserted after patient become unconscious. Endotracheal intubation will be done after giving atracurium 0.5 mg/kg. Patient will be c 35 Active-Treatment of Control Group
Experimental Group group III (bupivacaine - neostigmine group): the intervention will be started after induction of anesthesia and continued after end of surgery Patients of this group will receive intraoperative caudal analgesia by using bupivacaine 0.25% (0.75ml/kg) with neostigmine 2¿g/kg in 1ml normal saline. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children aged 2-8 years, of either gender, ASA I-II, undergoing elective surgeries for inguinal hernia repair will be enrolled in the study. Patients with the following conditions will excluded from the study: 1- Infection at the injection site. 2- coagulapathy 3-prexisting neurological diseases 4- Congenital anomalies 5- Allergy to one of the study drugs 2 Year(s) 8 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 01/04/2016 research ethics committee
Ethics Committee Address
Street address City Postal code Country
elgeish street tanta 5555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the primary outcome of this study will be to compare the duration of postoperative analgesia of caudal block when dexamethasone and neostigmine will be added to bupivacaine 0.25% in children. Post operative pain will be assessed by anesthesiology resident who will be blind to the caudal treatment by using the the modified objective pain score (MOPS)(16) at arrival to PACU, 30 min, 1h, 2h, 4h, 6h, 8h,12h and 24h postoperative.
Secondary Outcome Secondary outcomes will be the hemodynamic stability and postoperative complications. In the PACU, hemodynamics ( HR, MAP and SPO2 ) will be recorded every 5 minutes in the 1st 30 minutes then every 30 minutes till patient shifted to the ward.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
anesthesia department elgeish sreet tanta 1234 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university hospitals elgeish street tanta 7777 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospitals elgeish street tanta 7777 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
gehan morsy eid 7 thrwat street tanta 1147 Egypt
Shaimaa Farouk Abd El Kader 1 dwaran moheb elmahala elkobra 1111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gehan eid gehan2552011@gmail.com 01287466651 7 thrwat street
City Postal code Country Position/Affiliation
tanta 1147 Egypt Lecturer of Anaesthesia and and Intesive care
Role Name Email Phone Street address
Public Enquiries shaimaa abd elkader shaimaafarouk7777@yahoo.com 01270440771 1 dwaran moheb
City Postal code Country Position/Affiliation
elmahalla elkobra 1111 Egypt Lecturer of Anaesthesia and and Intesive care
Role Name Email Phone Street address
Scientific Enquiries mohammed abo elyazed mohd_yazed@yahoo.com 01120014472 15 elestad street
City Postal code Country Position/Affiliation
tanta Egypt Lecturer of Anaesthesia and and Intesive care
REPORTING
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