Postoperative PainNCT06599138
Maxillary and Mandibular Nerve Block. Block One Get One Free.
A study testing Ultrasound-guided maxillary nerve block in people with Postoperative Pain and Regional Anesthesia Morbidity, run by Servei Central d'Anestesiologia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Regional Anesthesia Morbidity
- What is being tested?
- Ultrasound-guided maxillary nerve block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 14 Nov 2024to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Embalmed cadaveric specimens without known maxillary disease
Who cannot join
- Embalmed cadaveric specimens with known maxillary disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Anestalia - Servei Central d'Anestesiologia
Barcelona, 08034
Gloria Molins, PhD, 0034610572824, molinsgloria@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain, Regional Anesthesia Morbidity
- Being tested
- Ultrasound-guided maxillary nerve block
- Keywords
- Maxillary nerve, Nerve block, Ultrasound
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided maxillary nerve blockDevice
Also called Maxillary nerve block
Suprazygomatic approach, ultrasound-guided infrazygomatic window, maxillary nerve block for injection of 2 - 5 ml of contrast
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Ultrasound-guided maxillary nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 hours (After performing the maxillary nerve block)
Secondary outcomes (1)
Spread of contrast to other locations
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.
Measured: 0 hours (After performing the maxillary nerve block)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Nov 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion16 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Servei Central d'Anestesiologia
- Sponsor type
- University, hospital or other
- Collaborators
- International University of Catalonia
- Responsible party
- Principal investigator, Gloria Molins Ballabriga, Servei Central d'Anestesiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599138
- Sponsor's protocol ID
- REST-INVI-2024-03
- Status last verified
- Nov 2024
- First submitted
- 1 Jun 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20199610Echaniz 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.
PubMed 31549339Kampitak 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.
PubMed 29659436Poore TE, Carney MT. Maxillary nerve block: a useful technique. J Oral Surg. 1973 Oct;31(10):749-55. No abstract available.
PubMed 4516663Fujii 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.
PubMed 1034732Singh 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.
PubMed 11707787Suresh 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.
PubMed 16918651Okuda 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.
PubMed 11464362Malamed SF, Trieger N. Intraoral maxillary nerve block: an anatomical and clinical study. Anesth Prog. 1983 Mar-Apr;30(2):44-8. No abstract available.
PubMed 6587797Sved 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.
PubMed 1444954Nique 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.
PubMed 6941133Stojcev 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.
PubMed 19959336Spinner 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.
PubMed 23043718Sahar 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.
PubMed 24977913Sola 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.
PubMed 22587691
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Maxillary Nerve Block: An Anatomical Cadaveric Study. Determination of Dispersion in Ultrasound-guided Suprazygomatic Maxillary Nerve Block in Cadavers.
- ClinicalTrials.gov ID
- NCT06599138
- Acronym / sponsor ID
- REST-INVI-2024-03
- Conditions
- Postoperative Pain, Regional Anesthesia Morbidity
- Keywords
- Maxillary nerve, Nerve block, Ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Servei Central d'AnestesiologiaUniversity, hospital or other
- Collaborators
- International University of Catalonia
- Study start
- 14 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 16 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection of 2ml in the pterygopalatine fossa | Other | Device: Ultrasound-guided maxillary nerve blockPerfom an ultrasound-guided maxillary nerve block with injection of 2 ml of contrast in the pterygopalatine fossa |
| Injection of 5ml in the pterygopalatine fossa | Other | Device: Ultrasound-guided maxillary nerve blockPerfom an ultrasound-guided maxillary nerve block with injection of 5 ml of contrast in the pterygopalatine fossa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Embalmed cadaveric specimens without known maxillary disease
Key exclusion criteria (1 listed)
- Embalmed cadaveric specimens with known maxillary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided maxillary nerve blockAlso: Maxillary nerve blockSuprazygomatic approach, ultrasound-guided infrazygomatic window, maxillary nerve block for injection of 2 - 5 ml of contrast | Device | Injection of 2ml in the pterygopalatine fossa, Injection of 5ml in the pterygopalatine fossa |
Primary outcome
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.
1 secondary outcome
Spread of contrast to other locations
Time frame: 0 hours (After performing the maxillary nerve block)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Background: PubMed 20199610Mesnil 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.
- Background: PubMed 31549339Echaniz 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.
- Background: PubMed 29659436Kampitak 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.
- Background: PubMed 4516663Poore TE, Carney MT. Maxillary nerve block: a useful technique. J Oral Surg. 1973 Oct;31(10):749-55. No abstract available.
- Background: PubMed 1034732Fujii 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.
- Background: PubMed 11707787Singh 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.
- Background: PubMed 16918651Suresh 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.
- Background: PubMed 11464362Okuda 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.
- Background: PubMed 6587797Malamed SF, Trieger N. Intraoral maxillary nerve block: an anatomical and clinical study. Anesth Prog. 1983 Mar-Apr;30(2):44-8. No abstract available.
- Background: PubMed 1444954Sved 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.
- Background: PubMed 6941133Nique 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.
- Background: PubMed 19959336Stojcev 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided maxillary nerve block in people with Postoperative Pain and Regional Anesthesia Morbidity, run by Servei Central d'Anestesiologia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spread of contrast to mandibular nerve branches (time frame: 0 hours (After performing the maxillary nerve block)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06599138, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.