Cleft Palate, Surgery
Conditions
Keywords
cleft palate, surgery, maxillary nerve block, local anesthetic, loco regional anesthesia, face nerve block
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.
Interventions
in the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block.
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Months to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of morphine consumption | up to 48 hours after cleft palate surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of consumption of perioperative morphine | up to one week after cleft palate surgery | evaluation of the consumption of perioperative morphine |
| Measure of the number of episodes of respiratory distress | up to one week after cleft palate surgery | Measure of the number of episodes of respiratory distress |
| Measure of the period of re-feeding | up to one week after cleft palate surgery | Measure of the period of re-feeding |
| Measure of the duration of hospitalization | up to one week after cleft palate surgery | Measure of the duration of hospitalization |
Contacts
PRINCIPAL_INVESTIGATORMatthieu Miclo, MD
CHU Amiens
PRINCIPAL_INVESTIGATOREmmanuel Lorne, Pr
CHU Amiens
PRINCIPAL_INVESTIGATORJérémie Garnier, MD
CHU Amiens
PRINCIPAL_INVESTIGATORMarie Trujillo-Garcia, MD
CHU Amiens
PRINCIPAL_INVESTIGATORDimitri Santarelli, MD
CHU Amiens
PRINCIPAL_INVESTIGATORCica Carole Gbaguidi, MD
CHU Amiens
Outcome results
None listed