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Does it Worth to Reinforce With Additional Anesthesia to Improve Postoperative Course After Orthognathic Surgery?

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ClinicalTrials.gov Identifier: NCT03974035
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Gloria Molins Ballabriga, Servei Central d' Anestesiologia

Brief Summary:
Bimaxillary osteotomy is a surgery procedure of the orthognathic surgery field for correction of dental and facial abnormalities, for both functional and aesthetic cases. The incidence of this abnormality is 5-10% of the population, and the etiology is unknown, with genetic, environmental and embryonic factors related. The surgery technic is complex, and requires osteotomy of the maxilla and jaw, which allows toward, forward, impact and rotation of these bones to fix the edges of the face. The anesthetic management of these patients is a challenge because of the difficult airway management and the perioperative pain control. Multimodal approach for pain control is a fact, and the use of local anesthesia is mandatory. The investigators propose the infiltration of local anesthesia in two different times, first pre-incision and second before awaking the patient, for a proper control of postoperative pain

Condition or disease Intervention/treatment Phase
Dentofacial Deformities Drug: Second infiltration pre-extubation with ropivacaine Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigators propose a double-blinded prospective comparative experimental study (patient and nurse). After the approval of the ethics committee of our hospital and the signed consent from each of the patients in the study, patients will be scheduled for bimaxillary osteotomy and will be randomly and prospectively assigned to one of the two groups with a plan to register up to 52 patients. Patients will not know the group that they have been assigned consecutively; and both the postoperative resuscitation nurses and the hospitalization nurses who will perform VAS records, opioid consumption, PONV and postoperative complications, will also be unaware of the analgesic treatment that the patient has received in the operating room. Patients will be assigned randomly to one group or another:
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Does it Worth to Reinforce With Additional Anesthesia to Improve Postoperative Course After Orthognathic Surgery?
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
Patients undergoing elective bimaxillary osteotomy who receive a preincisional infiltration of lidocaine and adrenaline.
Experimental: Study Group
Patients undergoing elective bimaxillary osteotomy who receive two infiltrations (firstly pre-incision with lidocaine and adrenaline, secondly pre-extubation with ropivacaine).
Drug: Second infiltration pre-extubation with ropivacaine
The surgeon will proceed firstly with pre-incisional infiltration with lidocaine and adrenaline after intubation, and secondly with pre-extubation infiltration with ropivacaine at the intraoral and intranasal submucosal level in the maxilla and jaw to block the terminal branches of the maxillary and mandibular nerve




Primary Outcome Measures :
  1. Pain assessed by the visual analogue scale (VAS) in the immediate postoperative period [ Time Frame: 2 hours postoperatively ]

    The main objective of the study is the evaluation of the effect of a peripheral pre-incisional minor nerve block with the use of a single local anesthetic (lidocaine), compared with the same nerve block in two times with different local anesthetics (lidocaine-preincisional and ropivacaine-pre-extubation), on the postoperative pain of patients undergoing elective bimaxillary osteotomy, evaluated by means of the visual analogue scale (VAS) of pain in the immediate postoperative period (2 hours postoperatively).

    The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The examiner scores the VAS by measuring the distance in centimeters (0 to 10) from the "no pain" anchor point.



Secondary Outcome Measures :
  1. Pain assessed by VAS at 4, 8 and up to 18 hours after surgery. [ Time Frame: 4, 8 and up to 18 hours after surgery ]

    The comparison of visual analogue scale (VAS) of pain at 4, 8 and up to 18 hours after surgery.

    The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The examiner scores the VAS by measuring the distance in centimeters (0 to 10) from the "no pain" anchor point.


  2. Opioid use of rescue (intravenous methadone milligrams) [ Time Frame: 2 and 18 hours postoperatively ]
    The comparison of the opioid use of rescue (intravenous methadone milligrams) in the immediate postoperative period in resuscitation (2 hours postoperatively) and in the hospitalization floor (18 hours postoperatively)

  3. Postoperative nausea and vomiting (PONV) [ Time Frame: 2 and 18 hours postoperatively ]
    Comparing the incidence of postoperative nausea and vomiting (PONV) in the immediate postoperative period in resuscitation and up to 18 hours after the surgery in the two groups of patients

  4. Complications derived from the two infiltrations [ Time Frame: Through surgery completion and 0 to 18 hours postoperatively ]
    Registry of complications derived from the two infiltrations



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who undergo scheduled bimaxillary surgery

Exclusion Criteria:

  • patients who are scheduled for bimaxillary surgery together with another complementary surgical procedure (such as mentoplasty, rhinoplasty, blepharoplasty)
  • age <18 years
  • reinterventions
  • urgent surgeries
  • allergies to local anesthetics
  • allergies to anti-inflammatories agents
  • allergies to opioids
  • American Society of Anesthesiology Physical Status Examination System (ASA) >3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974035


Contacts
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Contact: Gloria Molins, MD, MSc 0034610572824 molinsgloria@me.com
Contact: Adaia Valls, MD, DDS, PhD 0034626153539 avalls@institutomaxilofacial.com

Locations
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Spain
Centro Medico Teknon - Grupo Quirón Salud Recruiting
Barcelona, Spain, 08017
Contact: Gloria Molins    0034610572824    molinsgloria@me.com   
Contact: Adaia Valls    0034932906200 ext 2852    avalls@institutomaxilofacial.com   
Sponsors and Collaborators
Servei Central d' Anestesiologia
Investigators
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Study Director: Federico Hernández-Alfaro, MD, DDS, PhD Instituto Maxilofacial - Centro Médico Teknon
Study Director: Miriam DeNadal, MD, PhD Hospital Valle de Hebrón
  Study Documents (Full-Text)

Documents provided by Gloria Molins Ballabriga, Servei Central d' Anestesiologia:
Informed Consent Form  [PDF] May 11, 2019


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Responsible Party: Gloria Molins Ballabriga, Principal Investigator, Servei Central d' Anestesiologia
ClinicalTrials.gov Identifier: NCT03974035     History of Changes
Other Study ID Numbers: 1TDGM
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of the study completion
Access Criteria: data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gloria Molins Ballabriga, Servei Central d' Anestesiologia:
Local anesthesia
Ropivacaine

Additional relevant MeSH terms:
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Dentofacial Deformities
Congenital Abnormalities
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic System Abnormalities
Stomatognathic Diseases
Lidocaine
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action