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

NCT04023825 | Withdrawn

• 1 other identifier: PI2018_843_0020
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cleft Palate; Surgery

Keywords

cleft palate; surgery; maxillary nerve block; local anesthetic; loco regional anesthesia; face nerve block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

Patients will receive loco regional anesthesia

Drug: suprazygomatic maxillary nerve block

control group

NO INTERVENTION

Patients will not receive loco regional anesthesia

Interventions

suprazygomatic maxillary nerve block DRUG

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

experimental group

Eligibility Criteria

• Age: 5 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children between 5 months and 12 years old
• weight \>5kg
• children undergoing cleft palate repair surgery with or without upper lip surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Matthieu Miclo, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Emmanuel Lorne, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Jérémie Garnier, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Marie Trujillo-Garcia, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Dimitri Santarelli, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Cica Carole Gbaguidi, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share