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.: PACTR201511001350302 Date of Approval: 16/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Bilateral Suprazygomatic Maxillary and Bilateral Greater Palatine Nerve Block for Perioperative Analgesia during Palatoplasty
Official scientific title Comparative Study of Bilateral Suprazygomatic Maxillary and Bilateral Greater Palatine Nerve Block for Perioperative Analgesia in Children Undergoing Palatoplasty
Brief summary describing the background and objectives of the trial Regional anesthesia in pediatrics is recommended especially in congenital cleft palate (CP). Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are methods for regional block in CP. The aim of this study: to compare the analgesic effect and complications of bilateral Greater Palatine and Suprazygomatic Maxillary Nerve Blocks in children during Palatoplasty.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Analgesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/11/2014
Actual trial start date 01/12/2014
Anticipated date of last follow up 09/09/2015
Actual Last follow-up date 17/09/2015
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 randomization using table a statistica book 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
Experimental Group Group GPN bilateral greater palatine nerve block. preoperative 20
Experimental Group Group SMN bilateral suprazygomatic nerve block preoperative 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children from 6 months to 5 years old. ASA I-III. Scheduled to undergo palatoplasty. Bleeding disorders. Skin lesions or wounds at site of proposed needle insertion. Children having co-morbid conditions like congenital heart disease, respiratory pathology and CVS disorders. Children posted for combined procedures like palatoplasty with cheiloplasty or submucosal alveolar bone grafting. Known hypersensitivity to local anesthetics or opioids. Lack of parental consent. 6 Month(s) 5 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 03/08/2014 Cairo university
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy st. Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain assessment immediately postoperative and then every hour during the first 6 hours, after that every 2 hours for the following 6 hours using Objective behavioral pain score (OPS)
Secondary Outcome Hemodynamic parameters (systolic, diastolic arterial blood pressure and heart rate) Immediately after skin incision and every 10 minutes till the end of surgery.
Secondary Outcome Number of fentanyl doses required All through the procedure
Secondary Outcome Patients requiring rescue analgesia In the first 12 hours postoperative.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo faculty of medicine Kasr Elainy st. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo faculty of medicine Kasr Alainy st. Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Faculty of medicine Kasr Alainy st. Cairo Egypt Hospital
Primary Sponsor Cairo university Gamaa st. Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Anesthesia department Kasr Alainy st. Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elsonbaty jijsonbaty@yahoo.com +201000255200 Elharam st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Ahmed Abd El-Hamid bashaahmad@yahoo.com +201005204130 20 Ezz Eldin Omar st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Saad Ibrahim saadibrahim_7@yahoo.com +201223142889 Oman st.
City Postal code Country Position/Affiliation
Giza Egypt Professor
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