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

NCT03974035 | Completed Phase 2 DMC

• 1 other identifier: 1TDGM
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Dentofacial Deformities

Keywords

Local anesthesia; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain assessed by VAS at 4, 8 and up to 18 hours after surgery.

  4, 8 and up to 18 hours after surgery

• Opioid use of rescue (intravenous methadone milligrams)

  2 and 18 hours postoperatively

• Postoperative nausea and vomiting (PONV)

  2 and 18 hours postoperatively

• Complications derived from the two infiltrations

  Through surgery completion and 0 to 18 hours postoperatively

Study Arms (2)

Control Group

NO INTERVENTION

Patients undergoing elective bimaxillary osteotomy who receive a preincisional infiltration of lidocaine and adrenaline.

Study Group

EXPERIMENTAL

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

Interventions

Second infiltration pre-extubation with ropivacaine DRUG

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

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who undergo scheduled bimaxillary surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Servei Central d'Anestesiologia: lead

Study Sites (1)

Centro Medico Teknon - Grupo Quirón Salud

Barcelona, 08017, Spain

Location

MeSH Terms

Conditions

Dentofacial Deformities

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Federico Hernández-Alfaro, MD, DDS, PhD

  Instituto Maxilofacial - Centro Médico Teknon

  STUDY DIRECTOR

• Miriam DeNadal, MD, PhD

  Hospital Valle de Hebrón

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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:

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: June 4, 2019
• Study Start: January 10, 2018
• Primary Completion: January 20, 2020
• Study Completion: January 30, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

ES (1)