Effects of Ultrasound-guided Maxillary Nerve Block Performed After Bimaxillary Osteotomy in Adult Patients

NCT06460051 | Not Yet Recruiting

• 1 other identifier: 5TDGM
• Study Type: interventional
• Target: 50
• 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 and regional anaesthesia is mandatory. The investigators propose bilateral ultrasound-guided suprazigomatic maxillary nerve block after bimaxillary osteotomy for a proper control of postoperative pain.

Conditions

Maxillary Diseases; Pain, Postoperative; Adult Patients Undergoing Bimaxillary Osteotomy

Keywords

Orthognatic surgery; Bimaxillary osteotomy; Maxillary nerve block; Ultrasound; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Inmediate Postoperative pain

  Postoperative pain in patients undergoing elective bimaxillary osteotomy, evaluated using the visual analog pain scale in the immediate postoperative period (2 hours postoperative). VAS: Visual analogue scale (0=minimum pain - 10=maximum pain)

  2 hours postoperatively

Secondary Outcomes (6)

• Pain at 8 hours postoperatively

  8 hours postoperatively

• Pain 18 hours after surgery

  18 hours postoperatively

• Inmediate Use of Opioids

  2 hours postoperatively

• Use of rescue opioids from 2 to 18 hours postoperatively

  2 to 18 hours postoperatively

• Incidence of immediate postoperative nausea and vomiting

  2 hours postoperatively

Study Arms (2)

Maxillary nerve block before bimaxillary osteotomy

ACTIVE COMPARATOR

Patients receive ultrasound-guided suprazigomatic maxillary nerve block after nasotracheal intubation before bimaxillary osteotomy.

Procedure: Maxillary nerve block

Maxillary nerve block after bimaxillary osteotomy

EXPERIMENTAL

Patients receive ultrasound-guidedsuprazygomatic maxillary nerve block after bimaxillary osteotomy before extubation.

Procedure: Maxillary nerve block

Interventions

Maxillary nerve block PROCEDURE

Ultrasound-guided, suprazygomatic approach, infrazygomatic window

Also known as: Ultrasound-guided maxillary nerve block

Maxillary nerve block after bimaxillary osteotomy; Maxillary nerve block before bimaxillary osteotomy

Eligibility Criteria

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

You may qualify if:

• Patients undergoing scheduled bimaxillary surgery

You may not qualify if:

• refusal to participate in the study
• patients scheduled for bimaxillary surgery together with another complementary surgical procedure (such as rhinoplasty, blepharoplasty)
• age \< 18 years
• reinterventions
• urgent surgeries
• allergies to local anesthetics
• allergies to anti-inflammatories
• allergies to opioids
• ASA ≥3.

Sponsors & Collaborators

• Servei Central d'Anestesiologia: lead

Study Sites (1)

Servei Central d'Anestesiologia Centro Medico Teknon

Barcelona, 08034, Spain

Location

Related Publications (11)

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  PMID: 27114091 BACKGROUND

• Budharapu A, Sinha R, Uppada UK, Subramanya Kumar AV. Ropivacaine: a new local anaesthetic agent in maxillofacial surgery. Br J Oral Maxillofac Surg. 2015 May;53(5):451-4. doi: 10.1016/j.bjoms.2015.02.021. Epub 2015 Mar 24.

  PMID: 25818492 BACKGROUND

• Cuvillon P, Nouvellon E, Ripart J, Boyer JC, Dehour L, Mahamat A, L'hermite J, Boisson C, Vialles N, Lefrant JY, de La Coussaye JE. A comparison of the pharmacodynamics and pharmacokinetics of bupivacaine, ropivacaine (with epinephrine) and their equal volume mixtures with lidocaine used for femoral and sciatic nerve blocks: a double-blind randomized study. Anesth Analg. 2009 Feb;108(2):641-9. doi: 10.1213/ane.0b013e31819237f8.

  PMID: 19151302 BACKGROUND

• Sisk AL. Vasoconstrictors in local anesthesia for dentistry. Anesth Prog. 1992;39(6):187-93.

  PMID: 8250339 BACKGROUND

• Mesnil M, Dadure C, Captier G, Raux O, Rochette A, Canaud N, Sauter M, Capdevila X. A new approach for peri-operative analgesia of cleft palate repair in infants: the bilateral suprazygomatic maxillary nerve block. Paediatr Anaesth. 2010 Apr;20(4):343-9. doi: 10.1111/j.1460-9592.2010.03262.x. Epub 2010 Feb 23.

  PMID: 20199610 BACKGROUND

• Sola C, Raux O, Savath L, Macq C, Capdevila X, Dadure C. Ultrasound guidance characteristics and efficiency of suprazygomatic maxillary nerve blocks in infants: a descriptive prospective study. Paediatr Anaesth. 2012 Sep;22(9):841-6. doi: 10.1111/j.1460-9592.2012.03861.x. Epub 2012 May 15.

  PMID: 22587691 BACKGROUND

• Chiono J, Raux O, Bringuier S, Sola C, Bigorre M, Capdevila X, Dadure C. Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. Anesthesiology. 2014 Jun;120(6):1362-9. doi: 10.1097/ALN.0000000000000171.

  PMID: 24525630 BACKGROUND

• Bouzinac A, Tournier JJ, Dao M, Delbos A. Ultrasound-guided maxillary nerve block in adults: feasibility and efficiency for postoperative analgesia after maxillary osteotomy. Minerva Anestesiol. 2014 Jul;80(7):860-1. Epub 2014 Jan 29. No abstract available.

  PMID: 24472751 BACKGROUND

• Wang YH, Wang DR, Liu JY, Pan J. Local anesthesia in oral and maxillofacial surgery: A review of current opinion. J Dent Sci. 2021 Oct;16(4):1055-1065. doi: 10.1016/j.jds.2020.12.003. Epub 2020 Dec 17.

  PMID: 34484571 BACKGROUND

• 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 BACKGROUND

• Gocmen G, Ozkan Y. Comparison of the Efficacy of Local Infiltration and Mandibular Block Anesthesia With Articaine for Harvesting Ramus Grafts. J Oral Maxillofac Surg. 2016 Nov;74(11):2143-2150. doi: 10.1016/j.joms.2016.05.008. Epub 2016 May 20.

  PMID: 27294877 BACKGROUND

MeSH Terms

Conditions

Maxillary Diseases; Pain, Postoperative

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Gloria Molins, MD, PhD

CONTACT

0034610572824; molinsgloria@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A 1:1 randomization table for patient allocation will be generated by a statistician who will not otherwise be involved in the study. Immediately upon the patient's arrival to the operating room, the research anesthesiologist will open a sealed, sequentially numbered opaque envelope containing the patient's assignment (block before surgery or block after surgery). Only anesthesiologists and operating room surgeons will not be blinded to patient assignment. This will be a double-blind study (patient and nurse). Patients will be unaware of the group they have been consecutively assigned to; and both the postoperative resuscitation nurses and the hospitalization ward nurses who will record visual analogue scale, analgesic consumption, onset of oral tolerance, postoperative nausea-vomiting and postoperative complications, will also be unaware of the analgesic treatment that the patient has received in the operating room.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The researchers propose a double-blind (patient and nurse) prospective comparative experimental study. The patients included in the study will be scheduled for bimaxillary osteotomy and will be assigned consecutively and prospectively to one of the two groups (maxillary nerve block before surgery or block after surgery) with a plan to register up to 50 patients.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 14, 2024
• Study Start: November 15, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 20, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: August 2024

Locations

ES (1)