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

Centre Hospitalier Universitaire, Amiens

Status

Withdrawn

Conditions

Cleft Palate

Surgery

Treatments

Drug: suprazygomatic maxillary nerve block

Study type

Interventional

Funder types

Other

Identifiers

NCT04023825

PI2018_843_0020

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

5 months to 12 years old

Volunteers

No Healthy Volunteers

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