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

Centre Hospitalier Universitaire, Amiens

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Cleft Palate Surgery

Interventions

suprazygomatic maxillary nerve blockDRUG

in the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block.

Eligibility

Sex: ALLMin age: 5 MonthsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: up to 48 hours after cleft palate surgery

Secondary Outcomes

Change from baseline of consumption of perioperative morphine

evaluation of the consumption of perioperative morphine

Time frame: up to one week after cleft palate surgery

Measure of the number of episodes of respiratory distress

Time frame: up to one week after cleft palate surgery

Measure of the period of re-feeding

Time frame: up to one week after cleft palate surgery

Measure of the duration of hospitalization

Time frame: up to one week after cleft palate surgery

Data from ClinicalTrials.gov

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