Maxillary and Mandibular Nerve Block

ConditionAnalgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMansoura University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) I/II patients,

within the age group of 21-60 years

both sex

scheduled for elective faciomaxillary surgery

Disqualifiers

Pregnant or breast-feeding women

Patients with polytrauma

Patients necessitating postoperative ventilation

Oral or facial infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Maxillary and mandibular nerve block

    Procedure/Surgery

    receive bilateral combined maxillary and mandibular nerve block

  • Control

    Other intervention

    not receive any nerve block

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Maxillary and mandibular nerve block (MMNB) groupActive comparator 1 intervention
Group B: Control (C) groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total postoperative fentanyl rescue analgesic consumption

microgram

Time frame
first 24 hours postoperatively

Secondary outcomes

1

Intraoperative heart rate (HR)

beats per minute

Time frame
each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
2

Intraoperative mean arterial pressure (MAP)

mmHg

Time frame
each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
3

10-cm visual analogue scale (VAS)

where 0 represented no pain, and 10 meant the worst possible pain

Time frame
at 0, 2, 4, 6, 8, 12, and 24 hours postoperatively
4

Postoperative analgesic duration

hours

Time frame
up to 24 hours (the time from ending of the nerve block till the first rescue morphine dose)

Other outcomes

Sponsors and contacts

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