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.: PACTR201707002365209 Date of Approval: 19/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title infrazygomatic maxillary nerve
Official scientific title Ultrasound guided bilateral infrazygomatic maxillary nerve block for cleft palate repair in children: a prospective randomized controlled study
Brief summary describing the background and objectives of the trial Cleft lip and/or palate are considered to be the most frequently encountered craniofacial malformation 1,2. Early surgery is necessary to reduce phonation and feeding difficulties and reduce complications such as frequent sinusitis and other respiratory tract infections 3,4. The surgical procedure can be complicated by airway obstruction and respiratory complications 2,5. Administration of opioids, often needed for intra- and postoperative analgesia, increases the risk of airway obstruction and promotes ventilatory control dysfunction 2,6. Regional anesthesia has a number of advantages and can provide postoperative analgesia in infants and neonates, without the risk of respiratory depression 7. Maxillary nerve block within the pterygopalatine fossa can provide sensory blockade of the hard and soft palate and, in this way, provide intra-operative and postoperative analgesia 8. The use of ultrasonographic guidance for regional anesthesia has recently been shown to be beneficial in children, mainly by limiting the puncture complications and block failures 9. The benefits of this technique are the visualization of key anatomic landmarks and confirmation of correct local anesthetic (LA) spread 10. The aim of this study is to evaluate the effects of bilateral ultrasound guided infrazygomatic maxillary nerve block on duration of analgesia and postoperative analgesic consumption in pediatric patients undergoing cleft palate repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2017
Actual trial start date 01/07/2017
Anticipated date of last follow up 01/11/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
31510/04/17 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 randomisation 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 Control group (C) bilateral sham ultrasound guided infrazygomatic maxillary nerve block using 0.15 ml/kg normal saline once bilateral sham ultrasound guided infrazygomatic maxillary nerve block 30 Placebo
Experimental Group Maxillary block group (M) bilateral ultrasound guided infrazygomatic maxillary nerve block (IMB) using 0.15 ml/kg of 0.2% ropivacaine over 20 s. once over 20 sec infrazygomatic maxillary nerve block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged 3 months - 2 years, of either gender, ASA I-II, scheduled for surgical cleft palate repair Lack of parental consent, patients with allergy to local anesthetic, cutaneous infection, or wound close to the puncture point 3 Month(s) 2 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 01/04/2017 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
10 Algeish street Tanta 31951 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain Scale (CHIPPS) score on admission to PACU 1h 2h 4h 6h 8h 12h 24h
Secondary Outcome ¿ Duration of analgesia time from block administration to the first administered dose of rescue analgesia
Secondary Outcome ¿ Postoperative analgesic consumption. after 24h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 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 Tanta University, Faculty of Medicine 10 Algeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 1 Moheb street Almahalla Alkobra 31951 Egypt
Mohamed Mohye Eldin 55 Stad street Tanta Egypt
Gehan Morsy 5 Tharwat street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra 31951 Egypt Lecturer ofanesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra 31951 Egypt Lecturer ofanesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer ofanesthesia 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