Ultrasound-guided Bilateral Suprazygomatic Maxillary Nerve Block and Bimaxillary Osteotomy

NCT03913429 | Completed DMC

• 1 other identifier: SCAnestalia
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentofacial Deformities; Regional Anesthesia Morbidity

Keywords

Orthognathic Surgery; Maxillary nerve blockade

Outcome Measures

Primary Outcomes (2)

• Opioids consumption

  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).

  2hours postoperatively

• comparison of the use of opioids in the intraoperative period

  comparison of the use of opioids in the intraoperative period (Target Controlled Infusion (TCI) ng / ml - intravenous remifentanil),

  intraoperatively

Secondary Outcomes (3)

• comparison of the use of rescue opioids in the postoperative period in hospitalization

  (2-18hours postoperative)

• the comparison of the incidence of immediate postoperative nausea and vomiting (PONV)

  0-18hours after surgery

• registry of complications derived from ultrasound-guided maxillary nerve block.

  0-18hours after surgery

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Study Group

EXPERIMENTAL

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

Interventions

Infiltration PROCEDURE

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

Also known as: Infiltration in the maxilla

Control Group

Maxillary nerve blockade PROCEDURE

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.

Also known as: Ultrasound guided Maxillary nerve blockade

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who undergo scheduled bimaxillary surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Servei Central d'Anestesiologia: lead

Study Sites (1)

Centro Medico Teknon - Grupo Quirón Salud

Barcelona, 08017, Spain

Location

Related Publications (1)

• Molins G, Valls-Ontanon A, De Nadal M, Hernandez-Alfaro F. Ultrasound-Guided Suprazygomatic Maxillary Nerve Block Is Effective in Reducing Postoperative Opioid Use Following Bimaxillary Osteotomy. J Oral Maxillofac Surg. 2024 Apr;82(4):412-421. doi: 10.1016/j.joms.2023.12.018. Epub 2024 Jan 2.

  PMID: 38253318 DERIVED

MeSH Terms

Conditions

Dentofacial Deformities

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

Study Officials

• Gloria Molins

  Anesthesiologist- Anestalia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: April 12, 2019
• Study Start: September 20, 2018
• Primary Completion: January 20, 2020
• Study Completion: January 30, 2020
• Last Updated: February 17, 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)