Maxillary and Mandibular Nerve Block

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Combined Maxillary and Mandibular Nerve Block on Orthognathic Surgery Outcomes

Conditions
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Analgesia

Intervention / Treatment
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* Procedure: Maxillary and mandibular nerve block
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) I/II patients, within the age group of 21-60 years both sex scheduled for elective faciomaxillary surgery Exclusion Criteria: Pregnant or breast-feeding women Patients with polytrauma Patients necessitating postoperative ventilation Oral or facial infection Coagulopathy Drug intake for chronic pain Known allergy to the study drugs Psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Maxillary and mandibular nerve block (MMNB) group<br>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. | Procedure: Maxillary and mandibular nerve block<br>* receive bilateral combined maxillary and mandibular nerve block<br>|
| Placebo Comparator: Control (C) group<br>not receive any nerve block | Other: Control<br>* not receive any nerve block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative fentanyl rescue analgesic consumption | microgram | first 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |