Dentofacial Deformities Clinical Trial
Official title:
Does it Worth to Reinforce With Additional Anesthesia to Improve Postoperative Course After Orthognathic Surgery?
Verified date | February 2020 |
Source | Servei Central d' Anestesiologia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 52 |
Est. completion date | January 30, 2020 |
Est. primary completion date | January 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Centro Medico Teknon - Grupo Quirón Salud | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Servei Central d' Anestesiologia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain assessed by the visual analogue scale (VAS) in the immediate postoperative period | 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. |
2 hours postoperatively | |
Secondary | Pain assessed by VAS at 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. |
4, 8 and up to 18 hours after surgery | |
Secondary | Opioid use of rescue (intravenous methadone milligrams) | 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) | 2 and 18 hours postoperatively | |
Secondary | Postoperative nausea and vomiting (PONV) | 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 | 2 and 18 hours postoperatively | |
Secondary | Complications derived from the two infiltrations | Registry of complications derived from the two infiltrations | Through surgery completion and 0 to 18 hours postoperatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05522348 -
Stability of Two Designs of Patient Specific Osteosynthesis For Fixation of LeFort 1 Osteotomy in Orthognathic Surgery
|
N/A | |
Completed |
NCT03913429 -
Ultrasound-guided Bilateral Suprazygomatic Maxillary Nerve Block and Bimaxillary Osteotomy
|
N/A | |
Recruiting |
NCT04117360 -
Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and Post-Treatment Analyses
|
||
Completed |
NCT03057223 -
Three-Dimensional Printing of Patient-Specific Titanium Plates in Jaw Surgery: A Pilot Study
|
N/A | |
Recruiting |
NCT06140043 -
Augmented Reality for Orthognatic Surgery Patient Education
|
Phase 2/Phase 3 | |
Completed |
NCT04863170 -
Cross Cultural Adaptation and Validation of Orthognathic Quality of Life Questionnaire (OQLQ)
|
||
Completed |
NCT06132906 -
Comparison Between Two Techniques to Reposition the Maxilla After le Fort 1
|
N/A | |
Recruiting |
NCT05151042 -
Digital Occlusal Wafer Versus Waferless Distal Segment Repositioning for BSSO in Skeletal Mandibular Deformities
|
N/A | |
Completed |
NCT04224805 -
The Use of Bone-borne Guides in Orthognathic Surgery Cases
|
N/A | |
Recruiting |
NCT05340036 -
Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony
|
N/A | |
Completed |
NCT05060133 -
Changes of the Upper Airway Volume After Orthognathic Surgery
|
||
Recruiting |
NCT02889432 -
Effects of Oral Melatonin on Neurosensory Recovery Following Facial Osteotomies
|
Phase 2 | |
Completed |
NCT02491619 -
Correlation Between Dental Inclination and Bone Thickness in Patients With Class III Dentofacial Deformities
|
N/A | |
Recruiting |
NCT05755022 -
3D Photogrammetry Versus Commercial Scanners for Accurate Repositioning of the Maxilla for Correction of the Dentofacial Deformity.
|
N/A | |
Active, not recruiting |
NCT03652155 -
Evaluating the Relationship Between Hard and Soft Tissue Advancement in Orthognathic Surgery
|
||
Recruiting |
NCT04635865 -
3D-Printed Patient-Specific Surgical Plates Versus Conventional Surgical Plates in Jaw Reconstruction
|
N/A | |
Active, not recruiting |
NCT03532828 -
Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients
|
N/A | |
Completed |
NCT04464252 -
Development and Validation of an Automated Three-dimensional Cephalometry Method
|
||
Recruiting |
NCT02639312 -
Natural History of Craniofacial Anomalies and Developmental Growth Variants
|