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.: PACTR201806003411404 Date of Approval: 23/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomized comparative prospective study of two different techniques for ultrasound-guided suprazygomatic maxillary nerve blocks in paediatrics
Official scientific title Randomized comparative prospective study of two different techniques for ultrasound-guided suprazygomatic maxillary nerve blocks in paediatrics
Brief summary describing the background and objectives of the trial Congenital cleft palate occurs in children at a rate of about 1.5 per 10 000 births and requires early surgery, in the first months of life. Airway obstruction and respiratory complications can occur following this painful surgical procedure. To decrease or avoid the use of morphine (or opioids) in the postoperative analgesia regimen, regional anesthesia has been highlighted in the recent pediatric literature. Mesnil et al. reported the efficiency of bilateral suprazygomatic maxillary blocks in terms of pain relief management after cleft palate repair in infants. 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 . The aim of this study is to evaluate two different techniques of ultrasound guided suprazygomatic maxillary nerve block in infants (pediatrics) to establish the most effective ultrasound guided method of blocking the maxillary nerve within the pterygopalatine fossa in this age group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cleft palate,Oral Health,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 28/05/2018
Actual trial start date
Anticipated date of last follow up 31/07/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 146
Actual target sample size (number of participants)
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 by a randomisation table created by computer 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 group Isuprazygomatic maxillary nerve once over 20 s on each side the needle will be placed adjacent to the lateral orbital wall at the midpoint of the orbital opening. The needle will be advanced in an inferior direction to reach the pterygopalatine fossathe needle will be introduced by out-of-plane approach, and the block will be performed bilaterally. After a negative aspiration test for blood, the injection of 0.15 ml/kg of 0.25% bupivacaine 73
Control Group group II suprazygomatic maxillary nerve blocks once over 20 s on each side Group II the needle will be placed at the frontozygomatic angle and then advanced medially until the pterygopalatine fossa is reached the needle will be introduced by out-of-plane approach, and the block will be performed bilaterally. After a negative aspiration test for blood, the injection of 0.15 ml/kg of 0.25% bupivacaine 73 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(ASA) physical status I or II surgical cleft palate repair paediatric lack of parental consent allergy to local anesthetics cutaneous infection wound close to the puncture point Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Month(s) 48 Month(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 09/05/2018 alexandria university hospital ethics committee
Ethics Committee Address
Street address City Postal code Country
el azeritta square alexandria Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to evaluate the efficacy of bilateral SMB for postoperative pain relief in infants scheduled for CP repair. A decrease in total nalbuphine consumption at 24 h postoperative every 2 h for 8 h and every 4 h thereafter until 24 h
Secondary Outcome number and ease of puncture once
Secondary Outcome visibility of the needle in the out-of-plane approach once
Secondary Outcome isualization of the internal maxillary artery and spread of LA once
Secondary Outcome technical block failure once
Secondary Outcome systemic toxicity to LAs once
Secondary Outcome nausea& vomiting every 4 hours for 24 hours
Secondary Outcome local infections and hematoma post operative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university hospital El Azeritta aquare alexandria oooo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
alexandria university El Azeritta aquare alexandria oooo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shahira ahmed youssef el metainy El Azeritta aquare alexandria oooo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Aly Mahmoud Moustafa Ahmed El Azeritta aquare alexandria oooo Egypt
Tamer Ahmed Ghonim El Azeritta aquare alexandria oooo Egypt
Ola Zanaty El Azeritta aquare alexandria 0000 Egypt
Shahira ahmed youssef el metainy El Azeritta aquare alexandria oooo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator shahira el metainy shelmetainy@yahoo.com +201227498438 El azzerita squARE
City Postal code Country Position/Affiliation
Alexandria 0000 Egypt Prof of anesthesia alexandria university
Role Name Email Phone Street address
Public Enquiries shahira El metainy El metainy shelmetainy@yahoo.com +20122789438 el azerita sqaure
City Postal code Country Position/Affiliation
alexandria 0000 Egypt prof anaethsesia Alexandria university
Role Name Email Phone Street address
Scientific Enquiries shahira El metainy shelmetainy@yahoo.com +20122789438 el azerita sqaure
City Postal code Country Position/Affiliation
alexandria 0000 Egypt prof anaethsesia Alexandria university
REPORTING
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Result URL Hyperlinks
Changes to trial information