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NCT Number: NCT05925465

Maxillary and Mandibular Nerve Block

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maha Ahmed AboZeid

Al Mansurah, Mansoura, 35511, Egypt

Location status: Recruiting

Location contact

Maha A AboZeid

CONTACT

[email protected]

Shimaa A Shalaby, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maxillary and mandibular nerve block

Procedure

receive bilateral combined maxillary and mandibular nerve block

Control

Other

not receive any nerve block

Primary outcomes

  1. Total postoperative fentanyl rescue analgesic consumption

    Time frame: first 24 hours postoperatively

    microgram

Secondary outcomes

  1. Intraoperative heart rate (HR)

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

    beats per minute

  2. Intraoperative mean arterial pressure (MAP)

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

    mmHg

  3. 10-cm visual analogue scale (VAS)

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

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

  4. Postoperative analgesic duration

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

    hours

  5. Patients' satisfaction about their analgesia

    Time frame: 24 hours postoperatively

    on a scale from 1 (poor), 2 (fair) to 3 (good)

  6. Total postoperative diclofenac sodium consumption

    Time frame: 24 hours postoperatively

    mg

  7. The total Intraoperative supplementary fentanyl

    Time frame: during the intraoperative duration

    microgram

Study contacts

Contact information is provided by the study sponsor or research team.

Maha A AboZeid, MD

CONTACT

[email protected]

02-01019216192

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: nerve block

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 29, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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