Clinical trial NCT05925465: Maxillary and Mandibular Nerve Block
Official title: Effect of Combined Maxillary and Mandibular Nerve Block on Orthognathic Surgery Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total postoperative fentanyl rescue analgesic consumption
timeFrame: first 24 hours postoperatively
Secondary outcomes:
measure: Intraoperative heart rate (HR)
timeFrame: each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
measure: Intraoperative mean arterial pressure (MAP)
timeFrame: each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
measure: 10-cm visual analogue scale (VAS)
timeFrame: at 0, 2, 4, 6, 8, 12, and 24 hours postoperatively
measure: Postoperative analgesic duration
timeFrame: up to 24 hours (the time from ending of the nerve block till the first rescue morphine dose)
measure: Patients' satisfaction about their analgesia
timeFrame: 24 hours postoperatively
measure: Total postoperative diclofenac sodium consumption
timeFrame: 24 hours postoperatively
measure: The total Intraoperative supplementary fentanyl
timeFrame: during the intraoperative duration
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Maha Ahmed AboZeid
Study officials:
References: