Clinical trial
Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children
Name
PI2018_843_0020
Description
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.
Trial arms
Trial start
2019-07-01
Estimated PCD
2022-07-01
Trial end
2022-07-01
Status
Withdrawn
Treatment
suprazygomatic maxillary nerve block
in the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block.
Arms:
experimental group
Primary endpoint
Change from baseline of morphine consumption
up to 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-03-23
1 organization
1 product
2 indications
Organization
Centre Hospitalier Universitaire AmiensIndication
Cleft PalateIndication
Surgery