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

Surgery Clinical Trial

— Suprazyg  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04023825
• Other study ID #: PI2018_843_0020
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Palate
• Surgery

Intervention

Drug:
• suprazygomatic maxillary nerve block
in the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of morphine consumption	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.	up to 48 hours after cleft palate surgery
Secondary	Change from baseline of consumption of perioperative morphine	evaluation of the consumption of perioperative morphine	up to one week after cleft palate surgery
Secondary	Measure of the number of episodes of respiratory distress	Measure of the number of episodes of respiratory distress	up to one week after cleft palate surgery
Secondary	Measure of the period of re-feeding	Measure of the period of re-feeding	up to one week after cleft palate surgery
Secondary	Measure of the duration of hospitalization	Measure of the duration of hospitalization	up to one week after cleft palate surgery