Clinical trial NCT04023825: Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children
Official title: Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cleft Palate
Surgery
Keywords: cleft palate
surgery
maxillary nerve block
local anesthetic
loco regional anesthesia
face nerve block
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of morphine consumption
timeFrame: up to 48 hours after cleft palate surgery
Secondary outcomes:
measure: Change from baseline of consumption of perioperative morphine
timeFrame: up to one week after cleft palate surgery
measure: Measure of the number of episodes of respiratory distress
timeFrame: up to one week after cleft palate surgery
measure: Measure of the period of re-feeding
timeFrame: up to one week after cleft palate surgery
measure: Measure of the duration of hospitalization
timeFrame: up to one week after cleft palate surgery
Other outcomes:
Locations:
Study officials:
affiliation: CHU Amiens
name: Matthieu Miclo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Emmanuel Lorne, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Jérémie Garnier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Marie Trujillo-Garcia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Dimitri Santarelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Cica Carole Gbaguidi, MD
role: PRINCIPAL_INVESTIGATOR
References: