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Recruiting NCT05925465

Maxillary and Mandibular Nerve Block

No phase Interventional Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Maxillary and mandibular nerve block, Control.
Who it may be relevant to
Registry conditions: Analgesia. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure Maxillary and mandibular nerve block
    receive bilateral combined maxillary and mandibular nerve block
  • Other Control
    not receive any nerve block

Primary outcome measures

  • Total postoperative fentanyl rescue analgesic consumption [Time frame: first 24 hours postoperatively]
Secondary outcome measures (7)
  • Intraoperative heart rate (HR) [Time frame: each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively]
  • Intraoperative mean arterial pressure (MAP) [Time frame: each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively]
  • 10-cm visual analogue scale (VAS) [Time frame: at 0, 2, 4, 6, 8, 12, and 24 hours postoperatively]
  • Postoperative analgesic duration [Time frame: up to 24 hours (the time from ending of the nerve block till the first rescue morphine dose)]
  • Patients' satisfaction about their analgesia [Time frame: 24 hours postoperatively]
  • Total postoperative diclofenac sodium consumption [Time frame: 24 hours postoperatively]
  • The total Intraoperative supplementary fentanyl [Time frame: during the intraoperative duration]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Maha Ahmed AboZeid — Al Mansurah

Identifiers

NCT: NCT05925465 · Jaw nerve block

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗