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Ultrasound-guided Bilateral Suprazygomatic Maxillary Nerve Block and Bimaxillary Osteotomy

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ClinicalTrials.gov Identifier: NCT03913429
Recruitment Status : Active, not recruiting
First Posted : April 12, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Servei Central d' Anestesiologia

Brief Summary:
Bimaxillary osteotomy is a surgery procedure of the orthognathic surgery field with the aim to correct dental and facial abnormalities, for both functional and aesthetic cases. The incidence of this abnormality is 5-10% of the population, and its etiology is unknown, with genetic, environmental and embryonic factors related. The surgical technique is complex, and requires osteotomy of the maxillary 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 and regional anesthesia is mandatory. The investigators propose bilateral suprazygomatic maxillary nerve block for a proper control of postoperative pain after bimaxillary osteotomy.

Condition or disease Intervention/treatment Phase
Dentofacial Deformities Regional Anesthesia Morbidity Procedure: Infiltration Procedure: Maxillary nerve blockade Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ultrasound-guided Bilateral Suprazygomatic Maxillary Nerve Block on Postoperative Pain After Elective Bimaxillary Osteotomy in Adult Patients
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Control Group

Infiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla (blockage of terminal branches of the maxillary nerve) after intubation and previous to surgical incision.

A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 1amp Lidocaine 2% in physiological saline (SF) 100ml.

Procedure: Infiltration

Infiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla (blockage of terminal branches of the maxillary nerve) after intubation and previous to surgical incision.

A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 1amp Lidocaine 2% in physiological saline (SF) 100ml

Other Name: Infiltration in the maxilla

Experimental: Study Group

Bilateral ultrasound-guided maxillary nerve block by suprazygomatic route after intubation and previous to surgical incision performed by the anesthesiologist.

A total of 5ml of Ropivacaine 0.37% infiltrated on each side.

Procedure: Maxillary nerve blockade

Bilateral ultrasound-guided maxillary nerve block by suprazygomatic route after intubation and previous to surgical incision performed by the anesthesiologist.

A total of 5ml of Ropivacaine 0.37% infiltrated on each side. Together with adrenaline infiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla.

A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 110ml SF.

Other Name: Ultrasound guided Maxillary nerve blockade




Primary Outcome Measures :
  1. Opioids consumption [ Time Frame: 2hours postoperatively ]
    evaluation of the effectiveness of the bilateral ultrasound-guided blockade with ropivacaine by suprazygomatic route, compared to the peripheral infiltration of the nerve with lidocaine and adrenaline, on the consumption of opioids for control of perioperative pain of patients intervened of elective bimaxillary osteotomy, evaluated by means of the analogical visual scale of pain in the immediate postoperative period (2 hours postoperatively).

  2. comparison of the use of opioids in the intraoperative period [ Time Frame: intraoperatively ]
    comparison of the use of opioids in the intraoperative period (Target Controlled Infusion (TCI) ng / ml - intravenous remifentanil),


Secondary Outcome Measures :
  1. comparison of the use of rescue opioids in the postoperative period in hospitalization [ Time Frame: (2-18hours postoperative) ]
    comparison of the use of rescue opioids (milligrams of intravenous methadone) in the postoperative period in hospitalization (2-18hours postoperative)

  2. the comparison of the incidence of immediate postoperative nausea and vomiting (PONV) [ Time Frame: 0-18hours after surgery ]
    the comparison of the incidence of immediate postoperative nausea and vomiting (PONV) in resuscitation and up to 18 hours after surgery

  3. registry of complications derived from ultrasound-guided maxillary nerve block. [ Time Frame: 0-18hours after surgery ]
    registry of complications derived from ultrasound-guided maxillary nerve block.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients who undergo scheduled bimaxillary surgery

Exclusion Criteria:

  • the refusal to participate in the study,
  • 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 Anesthesiologists Physical Status Classification (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): NCT03913429


Locations
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Spain
Centro Medico Teknon - Grupo Quirón Salud
Barcelona, Spain, 08017
Sponsors and Collaborators
Servei Central d' Anestesiologia
Investigators
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Principal Investigator: Gloria Molins Anesthesiologist- Anestalia
  Study Documents (Full-Text)

Documents provided by Servei Central d' Anestesiologia:
Informed Consent Form  [PDF] April 26, 2018


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Responsible Party: Servei Central d' Anestesiologia
ClinicalTrials.gov Identifier: NCT03913429     History of Changes
Other Study ID Numbers: SCAnestalia
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 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 Servei Central d' Anestesiologia:
Orthognathic Surgery
Maxillary nerve blockade
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
Epinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents