Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Change from baseline of morphine consumption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Months to 12 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
experimental group
Patients will receive loco regional anesthesia
Intervention: suprazygomatic maxillary nerve block (Drug)
Outcomes
Primary Outcomes
Change from baseline of morphine consumption
Time Frame: 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 Outcomes
- Change from baseline of consumption of perioperative morphine(up to one week after cleft palate surgery)
- Measure of the number of episodes of respiratory distress(up to one week after cleft palate surgery)
- Measure of the period of re-feeding(up to one week after cleft palate surgery)
- Measure of the duration of hospitalization(up to one week after cleft palate surgery)