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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group BNAI+ | Experimental | Randomization process will be used to preoperatively assign patient's left or right side to receive inferior alveolar nerve block. At the end of the surgery, each patient will receive an inferior alveolar nerve block with 2ml of bupivacaine 0.5% on one side ;the other side will not be injected. This arm include the group of fracture which will receive an inferior alveolar nerve block with bupivacaine. All patient will receive during the postoperative period 1 gram of paracetamol each 8 hours. |
|
| Group BNAI- | No Intervention | Randomization process will be used to preoperatively assign patient's left or right side to receive inferior alveolar nerve block. At the end of the surgery, each patient will receive an inferior alveolar nerve block with 2ml of bupivacaine 0.5% on one side ;the other side will not be injected. This arm include the group of fracture which will not receive an inferior alveolar nerve block with bupivacaine ( control group). All patient will receive during the postoperative period 1 gram of paracetamol each 8 hours. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacain | Drug | At the end of the surgery, after wound closure, an inferior alveolar nerve block with 2ml bupivacaine 0,5 % will be realized. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | questionnaire with a numerical scale (0 - 10) | 8 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | questionnaire with a numerical scale (0 - 10) | 2, 4 , 12, 24 hours post-operatively |
| Adverse effects | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yasmine sanaa, MD | Contact | +21658330834 | yasmine.sanaa@gmail.com | |
| Issam Zairi, MD, PhD | Contact | 0021697300683 | przairi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles Nicole Hospital | Recruiting | Tunis | 1002 | Tunisia |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D008337 | Mandibular Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
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| 24 hours post-operatively |
| The number of instances of rescue analgesia | We will record the number of instances of rescue analgesia following the description of intense pain for each hemi-mandible group. | 24 hours post-operatively |
| Charles Nicolle Hospital of Tunis | Completed | Tunis | 1053 | Tunisia |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D000588 |
| Amines |