Analgesia, Anesthesia, Local, Mandible Fracture, Postoperative Pain
Conditions
Keywords
Mandibular Fracture, Postoperative pain, Inferior alveolar nerve block, Analgesia
Brief 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.
Interventions
DRUGBupivacain
At the end of the surgery, after wound closure, an inferior alveolar nerve block with 2ml bupivacaine 0,5 % will be realized.
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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 with bupivacaine.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 8 hours post-operatively | questionnaire with a numerical scale (0 - 10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of instances of rescue analgesia | 24 hours post-operatively | We will record the number of instances of rescue analgesia following the description of intense pain for each hemi-mandible group. |
| Post-operative pain | 2, 4 , 12, 24 hours post-operatively | questionnaire with a numerical scale (0 - 10) |
| Adverse effects | 24 hours post-operatively | questionnaire including the presence or absence of any abnormal sensations, change in taste, nausea, constipation, fever, diaphoresis, vomiting, light-headedness, palpitations, or headache. The notice of an hematoma or in infection at the site of the injection |
Countries
Tunisia
Contacts
Primary Contactyasmine sanaa, MD
Backup ContactIssam Zairi, MD, PhD
Outcome results
None listed