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

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-07-01

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.

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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.

Conditions

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Cleft Palate Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

Patients will receive loco regional anesthesia

Group Type EXPERIMENTAL

suprazygomatic maxillary nerve block

Intervention Type DRUG

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

control group

Patients will not receive loco regional anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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suprazygomatic maxillary nerve block

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

Intervention Type DRUG

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

Minimum Eligible Age

5 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No