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

November 4, 2024 updated by: Gloria Molins Ballabriga, Servei Central d'Anestesiologia

Ultrasound-guided Maxillary Nerve Block: An Anatomical Cadaveric Study. Determination of Dispersion in Ultrasound-guided Suprazygomatic Maxillary Nerve Block in Cadavers.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The second division of the trigeminal nerve, the maxillary nerve (MN), exits the cranial region of the face via the foramen rotundum. From there, it travels laterally and forward through the pterygopalatine fossa, passes through the infra-orbital foramen at the bottom of the pterygomaxillary fossa, and ends up on the floor of the orbit. The MN is a purely sensory nerve that delivers innervation to the lower eyelid, upper lip, cheek, upper dental arch, maxillary sinus, hard and soft palate, posterior nasal cavity, and nasal ala. Effective anesthesia of the maxillary area can be achieved by surgeon's submucosal infiltration, witch appears to change the operative environment, or by inserting a needle in the pterygopalatine fossa (PPF). Although anesthetic infiltration around the mouth cavity or surgical site is simpler to execute than a selective nerve block, it might not be practical in some circumstances, such as when the surgical site is infected or inflamed. Therefore, the maxillary nerve block is preferred over local anesthetic infiltration when the surgical field covers the second third of the face and beyond the oral cavity, for example in maxillary osteotomy. The MN block can also be used for procedures of neurodestruction using neurolytic agents, for permitting anatomic differential neural blockade, and for the diagnostic evaluation of facial pain to determine whether pain is sympathetic or somatic in origin. However, the MN block can result in a number of problems, including as temporal blindness, hematoma formation, diplopia, temporary ophthalmoplegia and ptosis, penetration of the orbit, and brainstem anesthesia. Two approaches for maxillary nerve block in the pterigopalatina fossa have been described: infrazygomatic and suprazygomatic. Several risks associated with the infrazygomatic route of the maxillary block have been described, including the possibility of maxillary artery puncture and orbital or skull penetration. The suprazygomatic approach to maxillary nerve block has been shown to be safer for treating people with trigeminal neuralgia and for the anesthetic management of surgeries of the mid face. The amount of anesthetic injected into the pterygopalatine fossa for MN block is linked to certain issues, whereas other complications are related to the specific anatomical approach used. The typical volume of the PPF in adults has been reported from investigations in dry skulls as close to one ml. However, when executing this block clinically, two to five milliliters are usually injected. As a result, the excess amount of local anesthetic may move intracranially or into the orbit through the infratemporal fossa. Meanwhile, the location of this remaining volume has not been formally investigated.

Due to its many benefits, including safety profile, convenience of use, and low radiation exposure, the use of ultrasound guiding for regional anesthetic and pain mitigation has grown in popularity. Key anatomical features can be identified with its assistance, and by seeing the needle tip as it advances, it facilitates ideal needle insertion. The use of ultrasound pictures has been linked to a variety of superficial to deep nerve blocks in relation to head and neck blocks. Thus, the use of ultrasound for maxillary nerve block for clinical purpose is now mandatory. Although a safe and reliable suprazygomatic MN block technique has been validated providing satisfactory analgesia for midface surgery and chronic maxillofacial pain syndromes, where the remaining local anesthesia diffuses after filling the pterygopalatine fossa in maxillary nerve block has not been formally investigated.

Some authors suggest that with the injection of sufficient volume into the PPF during the maxillary nerve block, some remaining volume could diffuse to the pterygomandibular space, suggesting a communication between the two. And these data could justify the reported high analgesic power of the maxillary nerve block in maxillofacial surgery, which in addition to blocking the branches of the maxillary nerve itself located in the PPF, could also block branches of the mandibular nerve located in the pterygomandibular space. Therefore, randomized controlled trials are needed to determine in greater detail the dispersion of the injected volume outside the PPF when the maxillary nerve block is performed.

The goal of this anatomical study is to identify the extent of local anesthesia spreaded that might influence anesthetic coverage and blockrelated complications.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08034
        • Anestalia - Servei Central d'Anestesiologia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Embalmed cadaveric specimens without known maxillary disease

Exclusion Criteria:

- Embalmed cadaveric specimens with known maxillary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Injection of 2ml in the pterygopalatine fossa
Perfom an ultrasound-guided maxillary nerve block with injection of 2 ml of contrast in the pterygopalatine fossa
Device: Ultrasound-guided maxillary nerve block
Suprazygomatic approach, ultrasound-guided infrazygomatic window, maxillary nerve block for injection of 2 - 5 ml of contrast
Other Names:
  • Maxillary nerve block
Other: Injection of 5ml in the pterygopalatine fossa
Perfom an ultrasound-guided maxillary nerve block with injection of 5 ml of contrast in the pterygopalatine fossa
Device: Ultrasound-guided maxillary nerve block
Suprazygomatic approach, ultrasound-guided infrazygomatic window, maxillary nerve block for injection of 2 - 5 ml of contrast
Other Names:
  • Maxillary nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spread of contrast to mandibular nerve branches
Time Frame: 0 hours (After performing the maxillary nerve block)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spread of contrast to other locations
Time Frame: 0 hours (After performing the maxillary nerve block)

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

Compare different volumes (2 and 5ml) of contrast injected into the pterygopalatine fossa to investigate the location of its dispersion away from the maxillary nerve.
0 hours (After performing the maxillary nerve block)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servei Central d'Anestesiologia

Collaborators

International University of Catalonia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 14, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 16, 2024

Study Registration Dates

First Submitted

June 1, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REST-INVI-2024-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Clinical Trials on Ultrasound-guided maxillary nerve block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe