<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299998</url>
  </required_header>
  <id_info>
    <org_study_id>CRC_GHN_2017_001</org_study_id>
    <nct_id>NCT03299998</nct_id>
  </id_info>
  <brief_title>Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption</brief_title>
  <official_title>Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption in Double-jaw Surgery, a Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background and Objectives: Double-jaw surgery is one of the most painful oral surgery,&#xD;
      requiring multimodal analgesia including controlled morphine pump and its secondary effects.&#xD;
      The aim of this study was to evaluate the effectiveness of face block (mandibulary and&#xD;
      maxillary block analgesia) on the first 24 hours on morphine consumption in patients admitted&#xD;
      for double jaw surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods: Patients undergoing double-jaw surgery between January 2015 and May 2017 were&#xD;
      enrolled. Patients were separated into 2 groups: patients receiving maxillary-mandibulary&#xD;
      nerve block and those no receiving it. The primary endpoint was the morphine consumption&#xD;
      within 24 hours post-surgery. Secondary endpoints were the intra-operative remifentanil&#xD;
      consumption, incidence of postoperative nausea and vomiting at 24 hours, morphine consumption&#xD;
      in recovery room, length of stay in hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">August 10, 2017</completion_date>
  <primary_completion_date type="Actual">July 25, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative morphine consumption within 24 hours post-surgery</measure>
    <time_frame>24 hours</time_frame>
    <description>Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peroperative remifentanil consumption</measure>
    <time_frame>End of surgery (2 hours in average)</time_frame>
    <description>Remifentanil consumption in µg.kg-1 during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative morphine consumption within 12 hours post-surgery</measure>
    <time_frame>12 hours</time_frame>
    <description>Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative morphine consumption within 48 hours post-surgery</measure>
    <time_frame>48 hours</time_frame>
    <description>Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Up to hospital discharge (5 days in average)</time_frame>
    <description>Delay between hospitalization date and date of hospital discharge</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">92</enrollment>
  <condition>Dento Facial Dysmorphism</condition>
  <arm_group>
    <arm_group_label>BLOCK+</arm_group_label>
    <description>Patients who underwent maxillary and mandibulary block before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BLOCK -</arm_group_label>
    <description>Patients who did not undergo maxillary and mandibulary block before surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Maxillary and mandibular blocks</intervention_name>
    <description>A Pajunk SonoPlex Stim needle 22G x 55 mm was used. For maxillary nerve block, needle was introduced next to the angle of the orbitae and the zygomatic ridge. The needle was sank until coming into contact of the temporal bone. It was then orientated to the controlateral nostril and sank of 1 cm. For mandibular block, needle was introduced in the pterygoid fossa under and perpendicularly to the zygomatic arch, and sank until the pterygoid process. The needle was then orientated towards controlateral orbitae and sank with neurostimulation. After a motor response at 0.6 milliampere (mA) and the disappearance of contraction at 0.3 mA, local mixture was injected. The mixing of local anesthesia was made of ropivacaine 5 mg/mL and clonidine 30 µg. Five mL were injected in every block for a total of 20 mL.</description>
    <arm_group_label>BLOCK+</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General anesthesia</intervention_name>
    <description>Anesthesia was standardized and provided using intravenous administration of propofol and remifentanil. Patients were mechanically ventilated with a mixture of air (50/50), and desflurane or sevoflurane, or Target-controlled infusion (TCI) propofol. One to 5 mg/kg of methyl-prednisolone were administered to reduce inflammatory response.</description>
    <arm_group_label>BLOCK -</arm_group_label>
    <arm_group_label>BLOCK+</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female who underwent double jaw surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Male and female who underwent double jaw surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  opposition to the study&#xD;
&#xD;
          -  an additional surgical procedure&#xD;
&#xD;
          -  preoperative consumption of morphine or derived from morphine&#xD;
&#xD;
          -  perioperative N20&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299998
org study id: CRC_GHN_2017_001
nct id: NCT03299998
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background and Objectives: Double-jaw surgery is one of the most painful oral surgery,
      requiring multimodal analgesia including controlled morphine pump and its secondary effects.
      The aim of this study was to evaluate the effectiveness of face block (mandibulary and
      maxillary block analgesia) on the first 24 hours on morphine consumption in patients admitted
      for double jaw surgery.
Methods: Patients undergoing double-jaw surgery between January 2015 and May 2017 were
      enrolled. Patients were separated into 2 groups: patients receiving maxillary-mandibulary
      nerve block and those no receiving it. The primary endpoint was the morphine consumption
      within 24 hours post-surgery. Secondary endpoints were the intra-operative remifentanil
      consumption, incidence of postoperative nausea and vomiting at 24 hours, morphine consumption
      in recovery room, length of stay in hospital.
observational model: Cohort
time perspective: Retrospective
measure: Cumulative morphine consumption within 24 hours post-surgery
time frame: 24 hours
description: Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).
measure: Peroperative remifentanil consumption
time frame: End of surgery (2 hours in average)
description: Remifentanil consumption in µg.kg-1 during surgery
measure: Cumulative morphine consumption within 12 hours post-surgery
time frame: 12 hours
description: Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).
measure: Cumulative morphine consumption within 48 hours post-surgery
time frame: 48 hours
description: Cumulative morphine consumption measured using patient controlled analgesia (PCA-pump).
measure: Hospital length of stay
time frame: Up to hospital discharge (5 days in average)
description: Delay between hospitalization date and date of hospital discharge
arm group label: BLOCK+
description: Patients who underwent maxillary and mandibulary block before surgery
arm group label: BLOCK -
description: Patients who did not undergo maxillary and mandibulary block before surgery.
intervention type: Procedure
intervention name: Maxillary and mandibular blocks
description: A Pajunk SonoPlex Stim needle 22G x 55 mm was used. For maxillary nerve block, needle was introduced next to the angle of the orbitae and the zygomatic ridge. The needle was sank until coming into contact of the temporal bone. It was then orientated to the controlateral nostril and sank of 1 cm. For mandibular block, needle was introduced in the pterygoid fossa under and perpendicularly to the zygomatic arch, and sank until the pterygoid process. The needle was then orientated towards controlateral orbitae and sank with neurostimulation. After a motor response at 0.6 milliampere (mA) and the disappearance of contraction at 0.3 mA, local mixture was injected. The mixing of local anesthesia was made of ropivacaine 5 mg/mL and clonidine 30 µg. Five mL were injected in every block for a total of 20 mL.
arm group label: BLOCK+
intervention type: Procedure
intervention name: General anesthesia
description: Anesthesia was standardized and provided using intravenous administration of propofol and remifentanil. Patients were mechanically ventilated with a mixture of air (50/50), and desflurane or sevoflurane, or Target-controlled infusion (TCI) propofol. One to 5 mg/kg of methyl-prednisolone were administered to reduce inflammatory response.
arm group label: BLOCK -
arm group label: BLOCK+
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: France
responsible party type: Sponsor
mesh term: Congenital Abnormalities
mesh term: Anesthetics
sharing ipd: No