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NCT04961554: OBloc
Evolution of Mouth Opening After Mandibular Block
trial testing loco-regional anesthesia in Trismus. Withdrawn.
2 April 2024
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 2 April 2023 |
| Primary completion | 2 April 2024 |
| Estimated completion | 2 April 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- loco-regional anesthesia
Conditions studied
- Trismus — all drugs for Trismus →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with Trismus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04961554
- Europe PMC full search
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Related trials
Other recruiting trials for Trismus
Currently open trials in the same condition.
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- NCT07180498 — Evaluation of the Effect of Tea Tree and Chlorhexidine Mouthwashes on Healing After Third Molar Extraction · NA · recruiting
- NCT06531083 — Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus · NA · recruiting
- NCT06734598 — Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy · Phase 4 · recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04961554 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 3 February 2023
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