Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-11-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Group GPN, 20 patients received bilateral greater palatine nerve block.
* Group SMN, 20 patients received bilateral suprazygomatic maxillary nerve block.
PREVENTION
SINGLE
Study Groups
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GPN
administrated bilateral greater palatine nerve block using levobupivacaine 0.25%
peripheral nerve block by 0.25% levobupivacaine
SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.
SMN
administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%.
peripheral nerve block by 0.25% levobupivacaine
SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.
Interventions
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peripheral nerve block by 0.25% levobupivacaine
SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* skin lesions or wounds at site of proposed needle insertion,
* congenital heart disease,
* respiratory or
* cardiovascular disorders,
* children scheduled for combined procedures like palatoplasty with cheiloplasty or submucosal alveolar bone grafting,
* known hypersensitivity to local anesthetics or opioids and
* lack of parental consent.
6 Months
5 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mohamed Elsonbaty
Principal Investigator
Locations
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Cairo University hospitals
Cairo, Manial, Egypt
anesthesia department at Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.
Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947.
3. Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
Diewert VM. Development of human craniofacial morphology during the late embryonic and early fetal periods. Am J Orthod. 1985 Jul;88(1):64-76. doi: 10.1016/0002-9416(85)90107-1.
Other Identifiers
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N-98-2019
Identifier Type: -
Identifier Source: org_study_id