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.: PACTR201703002080167 Date of Approval: 07/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine in Suprazygomatic maxillary nerve block in cleft palate surgery
Official scientific title Suprazygomatic maxillary nerve block in cleft palate surgery: the efficacy of adding Dexmedetomidine to bupivacaine
Brief summary describing the background and objectives of the trial Cleft palate is congenital anomalies with an incidence ranging from 0.1 to 1.1 per 1,000 births depending on the population group, requiring early surgery during the first months of life. CP repair is painful, necessitating high doses of intravenous (IV) opioids. Therefore, the risk of postoperative respiratory depression and airway obstruction is important, and continuous monitoring is required during the initial 24-h postoperative period. The maxillary nerve (MN) provides sensory innervation of the anterior and posterior palate, the upper dental arch, the maxillary sinus, and the posterior nasal cavity. The efficiency of bilateral suprazygomatic maxillary blocks in terms of pain relief management, decrease in opioid consumption, and early resumption of feeding after cleft palate repair in infants. ¿2 ¿ adrenergic receptors agonists had been the focus of interest for their sedative, analgesic, and perioperative sympatholytic effects, Dexmedetomidine and Clonidine had been reported to produce opioid sparing effects in the perioperative setting . Dexmedetomidine a potent ¿ 2 adrenoceptor agonist, is approximately 8 times more selective than Clonidine. The mechanism by which ¿2 ¿ adrenergic receptors agonist produces analgesia and sedation is not fully understood but likely to be multifactorial peripherally ¿ 2 agonist produces analgesia by reducing the release of norepinephrine and causing ¿ 2 receptor- independent inhibitor effect on nerve fiber action potential. Centrally ¿ 2 agonist produce analgesia and sedation by inhibition of substance P release in the nociceptive pathway at the level of the dorsal root neuron and by activation of ¿ 2 adrenoceptor in the locus coeruleus The aim of this study to compare the efficacy of adding dexmedetomidine to bupivacaine in suprazygomatic maxillary nerve block in cleft palate
Type of trial RCT
Acronym (If the trial has an acronym then please provide) perioperative analg
Disease(s) or condition(s) being studied cleft palate surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2016
Actual trial start date 23/03/2017
Anticipated date of last follow up 01/06/2017
Actual Last follow-up date 30/09/2019
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
30914/05/16 Research ethics committiee faculty of medicine tanta university
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program 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 bilateral suprazygomatic maxillary block with 0.15 ml per kg 0.25 percent bupivacaine only once Intra-operative before surgical incision suprazygomatic block will be performed bilaterally, after identification of bony landmark of point of entry. The needle was inserted perpendicular to the skin and advanced to reach the greater wing of the sphenoid at approximately 20 mm depth. The needle was then reoriented in a 20ºand 10º caudal direction toward the philtrum and advanced 35¿45 mm deep to the pterygopalatine fossa 40 Active-Treatment of Control Group
Experimental Group suprazygomatic maxillary block once Intra-operative before surgical incision suprazygomatic maxillary block 0.15 ml per kg 0.25 percent bupivacaine plus 0.5 µg per kg dexmedetomidine. Suprazygomatic block will be performed bilaterally, after identification of bony landmark of point of entry. The needle was inserted perpendicular to the skin and advanced to reach the greater wing of the sphenoid at approximately 20 mm depth. The needle was then reoriented in a 20ºand 10º caudal direction toward the philtrum and advanced 35¿45 mm deep to the pterygopalatine fossa 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
infants of American Society of Anesthesiologist (I, II), aged from 6 month to 5 year of both sex undergoing cleft palate repair will be enrolled in the study The lack of parental consent, allergy to local anesthetic, cutaneous infection or wound close to the puncture point 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 30/05/2016 Research ethics committe faculty of medicine tanta university
Ethics Committee Address
Street address City Postal code Country
El Gaish street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain at 2h, 4h, 6h, 8h, 12h, 16,20h and 24h after recovery
Secondary Outcome Time to feed after tracheal extubation first 24 hours after recovery
Secondary Outcome Side effects (technical block failure, systemic toxicity to LAs, nausea, vomiting, sedation, local infections, and hematoma owing to the puncture) were recorded
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospitals El-Gaish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University hospitals El-Gaish street Tanta 31528 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anesthesia department Faculty of medicine tanta university El-Gaish street Tanta 31527 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Radwa Fathy Mansour Elnady street Tanta 31516 Egypt
Mohammed Elbrol Abd Elgaleel st Tanta 31528 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Radwa Mansour rodywael@yahoo.com 00201005255397 Elnady Street
City Postal code Country Position/Affiliation
Tanta 31516 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Sameh Abd Elkhalik dr_sameh_100@yahoo.com 0201002977048 10th Mostafa Kamel street
City Postal code Country Position/Affiliation
Tanta 31528 Egypt lecturer of anesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Mohammed Elbrol moh7000@yahoo.com 0201063345623 Abd Elgaleel st
City Postal code Country Position/Affiliation
Tanta 31528 Egypt lecturer of anesthesia and ICU
REPORTING
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