Peripheral Nerve Block Techniques During Cleft Palate

Study Overview
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Brief Summary
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Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this study was to compare the analgesic effect as well as the incidence of complications associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing palatoplasty surgery.

Official Title
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Comparing Two Peripheral Nerve Block Techniques for Perioperative Analgesia During Cleft Palate Surgery in Pediatric Patients: Randomized Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: peripheral nerve block by 0.25% levobupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III scheduled to undergo palatoplasty Exclusion Criteria: bleeding disorders, 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The two study groups were: Group GPN, 20 patients received bilateral greater palatine nerve block. Group SMN, 20 patients received bilateral suprazygomatic maxillary nerve block.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GPN<br>administrated bilateral greater palatine nerve block using levobupivacaine 0.25% | Procedure: peripheral nerve block by 0.25% levobupivacaine<br>* 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.<br>|
| Experimental: SMN<br>administrated bilateral suprazygomatic nerve block using levobupivacaine 0.25%. | Procedure: peripheral nerve block by 0.25% levobupivacaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain score | Pain assessment was done immediately postoperative using Objective behavioral pain score | the first 12 postoperative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suprazygomatic, Maxillary, Palatine, Cleft Palate