Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children

Study Overview
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Brief Summary
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This is a monocentric prospective randomized simple-blind designed study evaluating the superiority of the suprazygomatic maxillary nerve block in analgesia after cleft palate surgery compared with a control group. Every two hours, nurses systematically reassess the patient's pain and adjust the analgesic medications. Analgesic requirement, incidence of respiratory complications, re-feeding time and the duration of hospitalization are evaluated.

Detailed Description
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Cleft palate is the most common congenital malformation and requires early surgery given the complications it generates. The surgical site involving the upper airways and the use of morphine are providers of respiratory complications. The suprazygomatic maxillary nerve block could considerably reduce the use of morphine in the postoperative period and thus the respiratory complications in addition to an optimal comfort for the patient. The primary endpoint was to evaluate morphine consumption during the first postoperative 48 hours after cleft palate surgery.

Official Title
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Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children

Conditions
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Cleft Palate, Surgery

Intervention / Treatment
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* Drug: suprazygomatic maxillary nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children between 5 months and 12 years old weight >5kg children undergoing cleft palate repair surgery with or without upper lip surgery Exclusion Criteria: inappropriate age weight <5kg abnormal blood coagulation local anesthetic contraindication (including levobupivacaine, as well as any other associated treatment administered in this clinical study, including opioids, general anesthetics such as ketamine or propofol, paracetamol or corticosteroids) local infection

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 12 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Patients will receive loco regional anesthesia | Drug: suprazygomatic maxillary nerve block<br>* in the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block.<br>|
| No Intervention: control group<br>Patients will not receive loco regional anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of morphine consumption | The main objective of this study is to compare the consumption of morphine during the first 48 hours after cleft palate surgery in a group of patients treated by realization of a suprazygomatic maxillary nerve block, compared to a control group. | up to 48 hours after cleft palate surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of consumption of perioperative morphine | evaluation of the consumption of perioperative morphine | up to one week after cleft palate surgery | 
| Measure of the number of episodes of respiratory distress | Measure of the number of episodes of respiratory distress | up to one week after cleft palate surgery | 
| Measure of the period of re-feeding | Measure of the period of re-feeding | up to one week after cleft palate surgery | 
| Measure of the duration of hospitalization | Measure of the duration of hospitalization | up to one week after cleft palate surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cleft palate, surgery, maxillary nerve block, local anesthetic, loco regional anesthesia, face nerve block