Evolution of Mouth Opening After Mandibular Block

NCT04961554 | Withdrawn

• 1 other identifier: APHP210543
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Trismus

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

Outcome Measures

Primary Outcomes (1)

• 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.

  during surgery

Secondary Outcomes (2)

• Assessement of Etiology of limited mouth opening (osteoradionecrosis, tumor, infection)

  during surgery

• Mallampati score

  before locoregional anesthesia

Study Arms (1)

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.

Other: loco-regional anesthesia

Interventions

loco-regional anesthesia OTHER

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.

Adult patients presenting with limited mouth opening

Eligibility Criteria

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

Study Population

Adult patients presenting with a limited mouth opening that does not allow intubation by videolaryngoscopy, with mandibular surgical pathology requiring general anesthesia

You may qualify if:

• 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

You may not qualify if:

• Allergy to local anesthetics
• Patient under judicial protection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Anesthésie-Réanimation Pôle Tête et Cou, Hôpital Pitié-Salpêtrière

Paris, France

Location

MeSH Terms

Conditions

Trismus; Pain

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claire Gourbeix, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 14, 2021
• Study Start: April 2, 2023
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: February 3, 2023

Record last verified: 2022-10

Locations

FR (1)