TrismusOBlocNCT04961554
Evolution of Mouth Opening After Mandibular Block
An observational study of Trismus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Trismus is an involuntary contracture of the masticatory muscles, blocking the opening of the jaw, first intermittent then permanent and irreducible. Trismus is the result of pain or spasm or even muscle fibrosis, due to infectious, inflammatory or tumoral involvement of the masticatory muscles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trismus
- What is being tested?
- loco-regional anesthesia
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2023to 2 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients presenting with a limited mouth opening that does not allow intubation by videolaryngoscopy, with mandibular surgical pathology requiring general anesthesia
Who may be able to join
- Age ≥ 18 years old
- Patient with a mouth opening defined as very limited (<20mm)
- Patient scheduled for mandibular surgery, with an indication for a V3 block for analgesic purposes
- Patient informed and not opposed to the study
Who cannot join
- Allergy to local anesthetics
- Patient under judicial protection
Trial locations and contacts
1 site in 1 country.
France1 site
Anesthésie-Réanimation Pôle Tête et Cou, Hôpital Pitié-Salpêtrière
Paris
About this study
Official title: Locoregional Anesthesia of the V3 and Limited Mouth Opening
Trismus is an involuntary contracture of the masticatory muscles, blocking the opening of the jaw, first intermittent then permanent and irreducible. Trismus is the result of pain or spasm or even muscle fibrosis, due to infectious, inflammatory or tumoral involvement of the masticatory muscles.
During any anesthesia, control of the patient's upper airways is a major issue. Orotracheal intubation is the gold standard. Trismus will therefore complicate this management of the airways. This trismus can prevent the realization of a classic intubation, by the inability to use a laryngoscope or video laryngoscope, in favor of awake fiberoptic intubation, a technique that causes discomfort during the procedure, then a state of post-traumatic stress.
Read more
Mandibular block is increasingly used in the analgesia of mandibular surgeries thanks to the simplicity of the technique and its good efficiency. It has been described that the mandibular locoregional anesthesia made it possible to remove the trismus due to a dental infection, allowing the realization of a surgical gesture under good conditions. In addition, authors have described V3 block as a technique that could improve the safety of anesthesia in patients with acute trismus, by avoiding the need for awake nasofibroscopy intubation. One study showed that performing locoregional anesthesia of the mandibular nerve improved the mouth opening in patients with mandibular fracture. The investigators wondered if this locoregional anesthesia could also work on other types of trismus such as infectious, tumoral and osteoradionecrosis trismus.
During preoperative consultation, anesthesists usually measure the mouth opening. In our study, anesthesists will also measure the mouth opening after performing locoregional anesthesia of the V3 nerve (mandibular block). In addition to the measurement made before the start of the anesthetic treatment, research provides for three other measurements of the mouth opening using a rule (millimeters), taken at different times : after sedation, after performing locoregional anesthesia and after curarization. The investigators will also collect the cause of the limited mouth opening, the duration of development. The investigators will study pain at rest and when opening the mouth, under sedation, when performing the block, then when opening the mouth after performing the block. The presence of edema next to the area of locoregional anesthesia, the type of product used for sedation and locoregional anesthesia, the intubation technique performed, as well as the difficulty experienced by the operator will be collected
Read the detailed description
The aim of this study is to avoid recourse to awake fiberoptic intubation, which causes discomfort during the procedure and post-traumatic stress disorder, in patients with a very limited mouth opening (less than 20mm) and who must undergo anesthesia general for mandibular surgery.
As a reminder, the definition of limited mouth opening (MO) is a lower 35mm mouth opening, according to the Société française d'anesthésie-réanimation (SFAR) recommendations. The investigators define a very limited mouth opening as a mouth opening that does not allow a video laryngoscope blade to be inserted into the patient's mouth (less than 20mm).
During preoperative consultation, anesthesists usually measure the mouth opening. In our study, anesthesists will also measure the mouth opening after performing locoregional anesthesia of the V3 nerve (mandibular block). In addition to the measurement made before the start of the anesthetic treatment, research provides for three other measurements of the mouth opening using a rule, taken at different times.
The management is carried out exclusively by the investigators, the latter being anesthetists. Thus, the evaluation of the different mouth openings using a ruler (in millimeters), the evaluation of the pain using the numerical scale, the administration of sedation, the realization of loco-regional anesthesia, intraoperative and postoperative anesthetic management will be carried out by one and the same person qualified in anesthesia for maxillofacial surgery.
In summary, six key steps for our study will be carried out by the anesthetist-resuscitator:
- Initial patient assessment with assessment of pain and mouth opening (millimeters)
- Introduction of sedation, and reassessment of pain and mouth opening (millimeters)
- Performing a locoregional anesthesia of the V3 for analgesic purposes
- Reassessment of pain, mouth opening (millimeters) at least 15 minutes from the block, and possibly the Mallampati score. Mallampati score is systematically noted as part of the treatment.
- Induction of anesthesia, and reassessment of the mouth opening after curarization.
- Assessment of the difficulty of intubation (difficulty in passing the videolaryngoscope blade, Cormack score applied to videolaryngoscopy).
The anesthetist who performs the locoregional anesthesia will collect the data using the standardized questionnaire created for the study, notifying the key clinical elements of airway management that are being research within the framework of care, according to the rules of good anesthesia practice.
These data, collected as part of the treatment, will be:
- The cause of the limited mouth opening
- The duration of development
- Pain at rest and when opening the mouth, then under sedation, when performing the block, then when opening the mouth after performing the block, using the digital scale
- The presence of edema next to the area of locoregional anesthesia of V3
- The type of product used for sedation and locoregional anesthesia
- The mouth opening (measured in millimeters using a ruler) before any gesture then after sedation, 15 minutes from the completion of the V3 nerve block, and after curarization.
- The investigators will also evaluate the evolution of the Mallampati score at the same time, as part of the treatment.
- The intubation technique performed, as well as the difficulty experienced by the operator.
These data will be pseudonymized.
- Conditions
- Trismus
- Being tested
- loco-regional anesthesia
- Keywords
- mandibular block, limited mouth opening, trismus, loco-regional anesthesia, pain, video laryngoscope, awake flexible fiberoptic intubation, difficult airway management, head and neck surgery, maxillofacial surgery
- Medical subject headings
- Trismus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loco-regional anesthesiaOther
demonstrate that the mouth opening (measured in millimeters) of a patient treated for mandibular surgery with a very limited opening (defined by a threshold less than 20mm, not allowing the passage of a video laryngoscope blade per route buccal) is more important after locoregional anesthesia of the V3 than before anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients presenting with limited mouth opening | Adult patients presenting with limited mouth opening not allowing intubation by videolaryngoscopy, on mandibular surgical pathology requiring general anesthesia. Receives: Other: loco-regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of patient's mouth opening
The main outcome is the measure of patient's mouth opening (in millimeters) in the minutes preceding and following the mandibular block.
The mouth opening will be measured using a ruler with 4 defined times:
- Before any anesthesia
- After sedation
- 15min from the realization of the loco-regional anesthesia
- After curarization, just before intubation. These different measurements will be carried out by a ruler, and by a single operator for these 4 measurements.
Measured: during surgery
Secondary outcomes (2)
Assessement of Etiology of limited mouth opening (osteoradionecrosis, tumor, infection)
Potentially predictive of the success of locoregional anesthesia on mouth opening
Measured: during surgery
Mallampati score
Predictive of intubation difficulty
Measured: before locoregional anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start2 Apr 2023 (estimated)
- Primary completion2 Apr 2024 (estimated)
- Study completion2 Apr 2024 (estimated)
Why it stopped: 1. Short defense deadline 2. Activity cessation of the maxillofacial surgery department at Pitié Salpêtrière hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrismusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Gourbeix, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961554
- Sponsor's protocol ID
- APHP210543
- Acronym
- OBloc
- Status last verified
- Oct 2022
- First submitted
- 5 Jul 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locoregional Anesthesia of the V3 and Limited Mouth Opening
- ClinicalTrials.gov ID
- NCT04961554
- Acronym / sponsor ID
- OBloc / APHP210543
- Conditions
- Trismus
- Keywords
- mandibular block, limited mouth opening, trismus, loco-regional anesthesia, pain, video laryngoscope, awake flexible fiberoptic intubation, difficult airway management
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 1. Short defense deadline 2. Activity cessation of the maxillofacial surgery department at Pitié Salpêtrière hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Apr 2023 (estimated)
- Primary completion
- 2 Apr 2024 (estimated)
- Study completion
- 2 Apr 2024 (estimated)
- First posted
- 14 Jul 2021 (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.
Trismus is an involuntary contracture of the masticatory muscles, blocking the opening of the jaw, first intermittent then permanent and irreducible. Trismus is the result of pain or spasm or even muscle fibrosis, due to infectious, inflammatory or tumoral involvement of the masticatory muscles.
During any anesthesia, control of the patient's upper airways is a major issue. Orotracheal intubation is the gold standard. Trismus will therefore complicate this management of the airways. This trismus can prevent the realization of a classic intubation, by the inability to use a laryngoscope or video laryngoscope, in favor of awake fiberoptic intubation, a technique that causes discomfort during the procedure, then a state of post-traumatic stress.
Mandibular block is increasingly used in the analgesia of mandibular surgeries thanks to the simplicity of the technique and its good efficiency. It has been described that the mandibular locoregional anesthesia made it possible to remove the trismus due to a dental infection, allowing the realization of a surgical gesture under good conditions. In addition, authors have described V3 block as a technique that could improve the safety of anesthesia in patients with acute trismus, by avoiding the need for awake nasofibroscopy intubation. One study showed that performing locoregional anesthesia of the mandibular nerve improved the mouth opening in patients with mandibular fracture. The investigators wondered if this locoregional anesthesia could also work on other types of trismus such as infectious, tumoral and osteoradionecrosis trismus.
During preoperative consultation, anesthesists usually measure the mouth opening. In our study, anesthesists will also measure the mouth opening after performing locoregional anesthesia of the V3 nerve (mandibular block). In addition to the measurement made before the start of the anesthetic treatment, research provides for three other measurements of the mouth opening using a rule (millimeters), taken at different times : after sedation, after performing locoregional anesthesia and after curarization. The investigators will also collect the cause of the limited mouth opening, the duration of development. The investigators will study pain at rest and when opening the mouth, under sedation, when performing the block, then when opening the mouth after performing the block. The presence of edema next to the area of locoregional anesthesia, the type of product used for sedation and locoregional anesthesia, the intubation technique performed, as well as the difficulty experienced by the operator will be collected
Detailed description
The aim of this study is to avoid recourse to awake fiberoptic intubation, which causes discomfort during the procedure and post-traumatic stress disorder, in patients with a very limited mouth opening (less than 20mm) and who must undergo anesthesia general for mandibular surgery.
As a reminder, the definition of limited mouth opening (MO) is a lower 35mm mouth opening, according to the Société française d'anesthésie-réanimation (SFAR) recommendations. The investigators define a very limited mouth opening as a mouth opening that does not allow a video laryngoscope blade to be inserted into the patient's mouth (less than 20mm).
During preoperative consultation, anesthesists usually measure the mouth opening. In our study, anesthesists will also measure the mouth opening after performing locoregional anesthesia of the V3 nerve (mandibular block). In addition to the measurement made before the start of the anesthetic treatment, research provides for three other measurements of the mouth opening using a rule, taken at different times.
The management is carried out exclusively by the investigators, the latter being anesthetists. Thus, the evaluation of the different mouth openings using a ruler (in millimeters), the evaluation of the pain using the numerical scale, the administration of sedation, the realization of loco-regional anesthesia, intraoperative and postoperative anesthetic management will be carried out by one and the same person qualified in anesthesia for maxillofacial surgery.
In summary, six key steps for our study will be carried out by the anesthetist-resuscitator:
- Initial patient assessment with assessment of pain and mouth opening (millimeters)
- Introduction of sedation, and reassessment of pain and mouth opening (millimeters)
- Performing a locoregional anesthesia of the V3 for analgesic purposes
- Reassessment of pain, mouth opening (millimeters) at least 15 minutes from the block, and possibly the Mallampati score. Mallampati score is systematically noted as part of the treatment.
- Induction of anesthesia, and reassessment of the mouth opening after curarization.
- Assessment of the difficulty of intubation (difficulty in passing the videolaryngoscope blade, Cormack score applied to videolaryngoscopy).
The anesthetist who performs the locoregional anesthesia will collect the data using the standardized questionnaire created for the study, notifying the key clinical elements of airway management that are being research within the framework of care, according to the rules of good anesthesia practice.
These data, collected as part of the treatment, will be:
- The cause of the limited mouth opening
- The duration of development
- Pain at rest and when opening the mouth, then under sedation, when performing the block, then when opening the mouth after performing the block, using the digital scale
- The presence of edema next to the area of locoregional anesthesia of V3
- The type of product used for sedation and locoregional anesthesia
- The mouth opening (measured in millimeters using a ruler) before any gesture then after sedation, 15 minutes from the completion of the V3 nerve block, and after curarization.
- The investigators will also evaluate the evolution of the Mallampati score at the same time, as part of the treatment.
- The intubation technique performed, as well as the difficulty experienced by the operator.
These data will be pseudonymized.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients presenting with limited mouth opening | – | Other: loco-regional anesthesiaAdult patients presenting with limited mouth opening not allowing intubation by videolaryngoscopy, on mandibular surgical pathology requiring general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting with a limited mouth opening that does not allow intubation by videolaryngoscopy, with mandibular surgical pathology requiring general anesthesia
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Patient with a mouth opening defined as very limited (<20mm)
- Patient scheduled for mandibular surgery, with an indication for a V3 block for analgesic purposes
- Patient informed and not opposed to the study
Key exclusion criteria (2 listed)
- Allergy to local anesthetics
- Patient under judicial protection
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 |
|---|---|---|
| loco-regional anesthesiademonstrate that the mouth opening (measured in millimeters) of a patient treated for mandibular surgery with a very limited opening (defined by a threshold less than 20mm, not allowing the passage of a video laryngoscope blade per route buccal) is more important after locoregional anesthesia of the V3 than before anesthesia. | Other | Adult patients presenting with limited mouth opening |
Primary outcome
Measure of patient's mouth opening
Time frame: during surgery
The main outcome is the measure of patient's mouth opening (in millimeters) in the minutes preceding and following the mandibular block. The mouth opening will be measured using a ruler with 4 defined times: * Before any anesthesia * After sedation * 15min from the realization of the loco-regional anesthesia * After curarization, just before intubation. These different measurements will be carried out by a ruler, and by a single operator for these 4 measurements.
2 secondary outcomes
Assessement of Etiology of limited mouth opening (osteoradionecrosis, tumor, infection)
Time frame: during surgery
Mallampati score
Time frame: before locoregional anesthesia
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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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. This study is not recruiting at the moment.
Claire Gourbeix, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trismus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 3 Feb 2023. 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 France. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of patient's mouth opening (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2023; AzTrials last refreshed its copy on 4 Nov 2026.