Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery (NCT06243263) | Clinical Trial Compass
UnknownPhase 4
Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery
Tunisia30 participantsStarted 2024-02-06
Plain-language summary
Pain following open reduction of mandibular fractures is the most reported complaint during the first 24 post-operative hours. The goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures.
The main question it aims to answer are:
* Does the inferior alveolar nerve block with bupivacaine reduce the intensity of pain after mandibular fracture surgery?
* Does the inferior alveolar nerve block with bupivacaine decrease the consumption of analgesics during the first 24 postoperative hours?
Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block.
The patient:
* Will be asked to estimate the pain score by the numerical rating scale during the first 24 postoperative hours for each fracture.
* They will be given rescue analgesia in case of intense pain. The number of uses of rescue analgesia will be noted.
Researchers will compare a group of fracture that will receive the inferior alveolar nerve block with bupivacaine with a group of fracture that will not receive the inferior alveolar nerve block, to see if regional anesthesia improve postoperative pain management of mandibular fractures.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with bifocal mandibular fractures ( with one fracture on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible )
* Proposed for open reduction and internal fixation of their fractures under general anesthesia;
* Having provided their informed and documented consent on a consent form.
Exclusion Criteria:
* Pathological mandibular fractures;
* History of mandibular fractures;
* Patients with bone involvement in the facial skeleton other than the two fractures of the mandibular dentate portion;
* Patients suffering from trigeminal neuralgia;
* Dental care performed in the month preceding the trauma;
* Patients who have not undergone surgical treatment with open reduction and internal fixation of their mandibular fractures;
* Patients on anticoagulants;
* Porphyrias;
* History of malignant hyperthermia;
* Known allergy to local anesthetics;
* Pregnancy or breastfeeding;
* Severe heart failure;
* Atrioventricular conduction disorders;
* Uncontrolled epilepsy;
* Hemostatic disorders;
* Non-cooperative patients.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.