Maxillary and Mandibular Nerve Block. Block One Get One Free.

NCT06599138 | Not Yet Recruiting

• 1 other identifier: REST-INVI-2024-03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound-guided maxillary nerve block is mandatory for perioperative pain management of surgeries involving the middle third of the face. The suprazygomatic approach to the maxillary nerve has proven to be the safest and most effective. The volume used for maxillary nerve block remains a matter of debate; and this study aims to compare and study the dispersion of 2 - 5ml injected into the ptergopalatine fossa, and to know the reach of the mandibular nerve with this block.

Conditions

Postoperative Pain; Regional Anesthesia Morbidity

Keywords

Maxillary nerve; Nerve block; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Spread of contrast to mandibular nerve branches

  To analyze the spread of 2 and 5 ml of injected contrast to branches of the mandibular nerve after suprazygomatic ultrasound-guided single injection into the pterigopalatina fossa.

  0 hours (After performing the maxillary nerve block)

Secondary Outcomes (1)

• Spread of contrast to other locations

  0 hours (After performing the maxillary nerve block)

Study Arms (2)

Injection of 2ml in the pterygopalatine fossa

OTHER

Perfom an ultrasound-guided maxillary nerve block with injection of 2 ml of contrast in the pterygopalatine fossa

Device: Ultrasound-guided maxillary nerve block

Injection of 5ml in the pterygopalatine fossa

OTHER

Perfom an ultrasound-guided maxillary nerve block with injection of 5 ml of contrast in the pterygopalatine fossa

Device: Ultrasound-guided maxillary nerve block

Interventions

Ultrasound-guided maxillary nerve block DEVICE

Suprazygomatic approach, ultrasound-guided infrazygomatic window, maxillary nerve block for injection of 2 - 5 ml of contrast

Also known as: Maxillary nerve block

Injection of 2ml in the pterygopalatine fossa; Injection of 5ml in the pterygopalatine fossa

Eligibility Criteria

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

You may qualify if:

• \- Embalmed cadaveric specimens without known maxillary disease

You may not qualify if:

• \- Embalmed cadaveric specimens with known maxillary disease

Sponsors & Collaborators

• Servei Central d'Anestesiologia: lead
• International University of Catalonia: collaborator

Study Sites (1)

Anestalia - Servei Central d'Anestesiologia

Barcelona, 08034, Spain

Location

Related Publications (19)

• 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

• Echaniz G, Chan V, Maynes JT, Jozaghi Y, Agur A. Ultrasound-guided maxillary nerve block: an anatomical study using the suprazygomatic approach. Can J Anaesth. 2020 Feb;67(2):186-193. doi: 10.1007/s12630-019-01481-x. Epub 2019 Sep 23.

  PMID: 31549339 BACKGROUND

• Kampitak W, Tansatit T, Shibata Y. A Novel Technique of Ultrasound-Guided Selective Mandibular Nerve Block With a Lateral Pterygoid Plate Approach: A Cadaveric Study. Reg Anesth Pain Med. 2018 Oct;43(7):763-767. doi: 10.1097/AAP.0000000000000760.

  PMID: 29659436 BACKGROUND

• Poore TE, Carney MT. Maxillary nerve block: a useful technique. J Oral Surg. 1973 Oct;31(10):749-55. No abstract available.

  PMID: 4516663 BACKGROUND

• Fujii A. [New technic for blocking the 2nd division of the trigeminal nerve. Experimental and clinical studies on "suprazygomatic route"]. Masui. 1976 Dec;25(13):1370-82. No abstract available. Japanese.

  PMID: 1034732 BACKGROUND

• Singh B, Srivastava SK, Dang R. Anatomic considerations in relation to the maxillary nerve block. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):507-11. doi: 10.1053/rapm.2001.26218.

  PMID: 11707787 BACKGROUND

• Suresh S, Voronov P. Head and neck blocks in children: an anatomical and procedural review. Paediatr Anaesth. 2006 Sep;16(9):910-8. doi: 10.1111/j.1460-9592.2006.02018.x.

  PMID: 16918651 BACKGROUND

• Okuda Y, Takanishi T, Shinohara M, Nagao M, Kitajima T. Use of computed tomography for mandibular nerve block in the treatment of trigeminal neuralgia. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):382. doi: 10.1053/rapm.2001.25059. No abstract available.

  PMID: 11464362 BACKGROUND

• Malamed SF, Trieger N. Intraoral maxillary nerve block: an anatomical and clinical study. Anesth Prog. 1983 Mar-Apr;30(2):44-8. No abstract available.

  PMID: 6587797 BACKGROUND

• Sved AM, Wong JD, Donkor P, Horan J, Rix L, Curtin J, Vickers R. Complications associated with maxillary nerve block anaesthesia via the greater palatine canal. Aust Dent J. 1992 Oct;37(5):340-5. doi: 10.1111/j.1834-7819.1992.tb00758.x.

  PMID: 1444954 BACKGROUND

• Nique TA, Bennett CR. Inadvertent brainstem anesthesia following extraoral trigeminal V2-V3 blocks. Oral Surg Oral Med Oral Pathol. 1981 May;51(5):468-70. doi: 10.1016/0030-4220(81)90002-5.

  PMID: 6941133 BACKGROUND

• Stojcev Stajcic L, Gacic B, Popovic N, Stajcic Z. Anatomical study of the pterygopalatine fossa pertinent to the maxillary nerve block at the foramen rotundum. Int J Oral Maxillofac Surg. 2010 May;39(5):493-6. doi: 10.1016/j.ijom.2009.11.002. Epub 2009 Dec 2.

  PMID: 19959336 BACKGROUND

• Spinner D, Kirschner JS. Accuracy of ultrasound-guided superficial trigeminal nerve blocks using methylene blue in cadavers. Pain Med. 2012 Nov;13(11):1469-73. doi: 10.1111/j.1526-4637.2012.01480.x. Epub 2012 Oct 8.

  PMID: 23043718 BACKGROUND

• Sahar Hafeez N, Sondekoppam RV, Ganapathy S, Armstrong JE, Shimizu M, Johnson M, Merrifield P, Galil KA. Ultrasound-guided greater palatine nerve block: a case series of anatomical descriptions and clinical evaluations. Anesth Analg. 2014 Sep;119(3):726-730. doi: 10.1213/ANE.0000000000000329.

  PMID: 24977913 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

• Nader A, Schittek H, Kendall MC. Lateral pterygoid muscle and maxillary artery are key anatomical landmarks for ultrasound-guided trigeminal nerve block. Anesthesiology. 2013 Apr;118(4):957. doi: 10.1097/ALN.0b013e31826d3dfc. No abstract available.

  PMID: 23059449 BACKGROUND

• Nader A, Kendall MC, De Oliveria GS, Chen JQ, Vanderby B, Rosenow JM, Bendok BR. Ultrasound-guided trigeminal nerve block via the pterygopalatine fossa: an effective treatment for trigeminal neuralgia and atypical facial pain. Pain Physician. 2013 Sep-Oct;16(5):E537-45.

  PMID: 24077204 BACKGROUND

• Nader A, Bendok BR, Prine JJ, Kendall MC. Ultrasound-Guided Pulsed Radiofrequency Application via the Pterygopalatine Fossa: A Practical Approach to Treat Refractory Trigeminal Neuralgia. Pain Physician. 2015 May-Jun;18(3):E411-5.

  PMID: 26000688 BACKGROUND

• Kampitak W, Tansatit T, Shibata Y. A Cadaveric Study of Ultrasound-Guided Maxillary Nerve Block Via the Pterygopalatine Fossa: A Novel Technique Using the Lateral Pterygoid Plate Approach. Reg Anesth Pain Med. 2018 Aug;43(6):625-630. doi: 10.1097/AAP.0000000000000790.

  PMID: 29677030 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: September 19, 2024
• Study Start: November 14, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 16, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

ES (1)