Analgesia
Conditions
Brief summary
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.
Interventions
PROCEDUREMaxillary and mandibular nerve block
receive bilateral combined maxillary and mandibular nerve block
OTHERControl
not receive any nerve block
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Nerve block will be done by an anesthesiologist who will not be involved in data collection to ensure blindness.
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative fentanyl rescue analgesic consumption | first 24 hours postoperatively | microgram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative heart rate (HR) | each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively | beats per minute |
| Intraoperative mean arterial pressure (MAP) | each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively | mmHg |
| 10-cm visual analogue scale (VAS) | at 0, 2, 4, 6, 8, 12, and 24 hours postoperatively | where 0 represented no pain, and 10 meant the worst possible pain |
| Postoperative analgesic duration | up to 24 hours (the time from ending of the nerve block till the first rescue morphine dose) | hours |
| Patients' satisfaction about their analgesia | 24 hours postoperatively | on a scale from 1 (poor), 2 (fair) to 3 (good) |
| Total postoperative diclofenac sodium consumption | 24 hours postoperatively | mg |
| The total Intraoperative supplementary fentanyl | during the intraoperative duration | microgram |
Countries
Egypt
Contacts
CONTACTMaha A AboZeid, MD
Outcome results
None listed