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.: PACTR201710002695410 Date of Approval: 15/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Maxillary versus palatal block for cleft palate
Official scientific title Bilateral suprazygomatic maxillary nerve block versus palatal block for cleft palate repair in children
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. The aim of this study is to compare the effects of bilateral suprazygomatic maxillary nerve block versus palatal block on duration of analgesia as well as perioperative 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 Nervous System Diseases,postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 01/10/2017
Actual Last follow-up date 01/11/2017
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
31586/06/17 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group ( C ) general anesthesia only 30 Placebo
Experimental Group Maxillary block group (M) 0.15 ml/kg of 0.25% bupivacaine over 20 s bilaterally once after induction of GA suprazygomatic Maxillary nerve block 30
Experimental Group Palatal block group (P) 0.5 ml of 0.25% bupivacaine at each point i.e. at greater palatine, lesser palatine and naso palatine foraminae on either side of the palate once after induction of GA Palatal block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 3 months - 2 years, either gender, ASA I-II, scheduled for surgical cleft palate repair Lack of parental consent, patients with allergy to local anesthetic, cutaneous infection infection 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 01/06/2017 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 24 h postoperative rescue analgesic consumption 24 h post operative
Secondary Outcome postoperative pain score (CHIPPS) on admission to PACU, 1 h 2 h 4h 6 h 8 h 12 h 18 h 24h
Secondary Outcome time to feed after tracheal extubation when occurs
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 31951 Egypt Hospital
Primary Sponsor Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 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 31951 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 of anesthesia 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 31951 Egypt assistant professor of anesthesia and ICU
REPORTING
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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