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Mandibular fractures are among the most common (60-70%) maxillofacial fractures observed in emergency rooms. In the closed reduction (non-surgical), the bone fragments are realigned manually or by using traction devices. The open reduction surgery of mandibular fractures should first ensure the restoration of the occlusion of the mandible to prevent postoperative malocclusion, followed by stabilization by means of rigid fixations such as plates, screws, and rigid intermaxillary blocks in order to minimise any nonunion, malunion, or delayed union of the fracture segments. These surgical procedures are associated with moderate postoperative pain, being the first 24 hours the most intense pain period. Maxillary and mandibular nerve blocks are performed in patients with refractory trigeminal neuralgia. However, there have been few studies evaluating the analgesic effects of these blocks for maxillofacial surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maxillary and mandibular nerve block (MMNB) group | Active Comparator | receive bilateral combined maxillary and mandibular nerve block. Three mL of 0.5% isobaric bupivacaine will be injected for each nerve block after negative aspiration of blood. |
|
| Control (C) group | Placebo Comparator | not receive any nerve block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxillary and mandibular nerve block | Procedure | receive bilateral combined maxillary and mandibular nerve block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total postoperative fentanyl rescue analgesic consumption | microgram | first 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative heart rate (HR) | beats per minute | each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively |
| Intraoperative mean arterial pressure (MAP) | mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maha A AboZeid, MD | Contact | 02-01019216192 | mahazed@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maha Ahmed AboZeid | Recruiting | Al Mansurah | Mansoura | 35511 | Egypt |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Patients will be randomized into one of two groups, each of 30 patients, by means of coded envelopes to receive bilateral combined maxillary and mandibular nerve block (MNB group) or not receive any nerve block (control group)
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Nerve block will be done by an anesthesiologist who will not be involved in data collection to ensure blindness.
| Control | Other | not receive any nerve block |
|
| each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively |
| 10-cm visual analogue scale (VAS) | where 0 represented no pain, and 10 meant the worst possible pain | at 0, 2, 4, 6, 8, 12, and 24 hours postoperatively |
| Postoperative analgesic duration | hours | up to 24 hours (the time from ending of the nerve block till the first rescue morphine dose) |
| Patients' satisfaction about their analgesia | on a scale from 1 (poor), 2 (fair) to 3 (good) | 24 hours postoperatively |
| Total postoperative diclofenac sodium consumption | mg | 24 hours postoperatively |
| The total Intraoperative supplementary fentanyl | microgram | during the intraoperative duration |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |