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RecruitingNCT05925465nerve blockUpdated Feb 17, 2026

Maxillary and Mandibular Nerve Block

An interventional study of Maxillary and mandibular nerve block and Control in Analgesia, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Mansoura University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Analgesia

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03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's planned enrollment of 60 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Maxillary and mandibular nerve block (MMNB) group

    receive bilateral combined maxillary and mandibular nerve block. Three mL of 0.5% isobaric bupivacaine will be injected for each nerve block after negative aspiration of blood.

    Procedure: Maxillary and mandibular nerve block

  • Placebo comparator
    Control (C) group

    not receive any nerve block

    Other: Control

Interventions

  • ProcedureMaxillary and mandibular nerve block

    receive bilateral combined maxillary and mandibular nerve block

  • OtherControl

    not receive any nerve block

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What researchers measure

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)

  5. Patients' satisfaction about their analgesia

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

    Time frame: 24 hours postoperatively

  6. Total postoperative diclofenac sodium consumption

    mg

    Time frame: 24 hours postoperatively

  7. The total Intraoperative supplementary fentanyl

    microgram

    Time frame: during the intraoperative duration

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Study locations

1 of 1 sites recruiting
  • Maha Ahmed AboZeid
    Al Mansurah, Mansoura 35511, Egypt
    • Maha A AboZeid · Contact · mahazed@yahoo.com
    • Shimaa A Shalaby, MD · Sub investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05925465
Lead sponsor
Mansoura University
Responsible party
maha abou-zeid (Assistant Professor of Anesthesia and Surgical Intensive Care, Mansoura University) — Principal investigator
First posted
Jun 29, 2023
Start date
Aug 1, 2023
Primary completion
Dec 28, 2027 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Feb 17, 2026

Study contacts

Maha A AboZeid, MD
Contact
mahazed@yahoo.com
02-01019216192

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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