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

Not Applicable

Withdrawn

• Conditions: Surgery; Cleft Palate
• Interventions: Drug: suprazygomatic maxillary nerve block

• Registration Number: NCT04023825
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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 Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-18
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	suprazygomatic maxillary nerve block	Patients will receive loco regional anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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