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

Primary Purpose

Cleft Palate, Surgery

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
suprazygomatic maxillary nerve block
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate focused on measuring cleft palate, surgery, maxillary nerve block, local anesthetic, loco regional anesthesia, face nerve block

Eligibility Criteria

5 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    experimental group

    control group

    Arm Description

    Patients will receive loco regional anesthesia

    Patients will not receive loco regional anesthesia

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Change from baseline of consumption of perioperative morphine
    evaluation of the consumption of perioperative morphine
    Measure of the number of episodes of respiratory distress
    Measure of the number of episodes of respiratory distress
    Measure of the period of re-feeding
    Measure of the period of re-feeding
    Measure of the duration of hospitalization
    Measure of the duration of hospitalization

    Full Information

    First Posted
    July 16, 2019
    Last Updated
    March 21, 2023
    Sponsor
    Centre Hospitalier Universitaire, Amiens
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04023825
    Brief Title
    Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children
    Acronym
    Suprazyg
    Official Title
    Analgesic Contribution of the Suprazygomatic Maxillary Nerve Block for Cleft Palate Surgery in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no participants enrolled
    Study Start Date
    July 1, 2019 (Actual)
    Primary Completion Date
    July 1, 2022 (Actual)
    Study Completion Date
    July 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire, Amiens

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cleft Palate, Surgery
    Keywords
    cleft palate, surgery, maxillary nerve block, local anesthetic, loco regional anesthesia, face nerve block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    Patients will receive loco regional anesthesia
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Patients will not receive loco regional anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    suprazygomatic maxillary nerve block
    Intervention Description
    in the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block.
    Primary Outcome Measure Information:
    Title
    Change from baseline of morphine consumption
    Description
    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.
    Time Frame
    up to 48 hours after cleft palate surgery
    Secondary Outcome Measure Information:
    Title
    Change from baseline of consumption of perioperative morphine
    Description
    evaluation of the consumption of perioperative morphine
    Time Frame
    up to one week after cleft palate surgery
    Title
    Measure of the number of episodes of respiratory distress
    Description
    Measure of the number of episodes of respiratory distress
    Time Frame
    up to one week after cleft palate surgery
    Title
    Measure of the period of re-feeding
    Description
    Measure of the period of re-feeding
    Time Frame
    up to one week after cleft palate surgery
    Title
    Measure of the duration of hospitalization
    Description
    Measure of the duration of hospitalization
    Time Frame
    up to one week after cleft palate surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matthieu Miclo, MD
    Organizational Affiliation
    CHU Amiens
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Emmanuel Lorne, Pr
    Organizational Affiliation
    CHU Amiens
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jérémie Garnier, MD
    Organizational Affiliation
    CHU Amiens
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marie Trujillo-Garcia, MD
    Organizational Affiliation
    CHU Amiens
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Dimitri Santarelli, MD
    Organizational Affiliation
    CHU Amiens
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Cica Carole Gbaguidi, MD
    Organizational Affiliation
    CHU Amiens
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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