Maxillary and Mandibular Nerve Block

NCT ID: NCT05925465

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Nerve block will be done by an anesthesiologist who will not be involved in data collection to ensure blindness.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Maxillary and mandibular nerve block

Intervention Type PROCEDURE

receive bilateral combined maxillary and mandibular nerve block

Control (C) group

not receive any nerve block

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

not receive any nerve block

Interventions

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Maxillary and mandibular nerve block

receive bilateral combined maxillary and mandibular nerve block

Intervention Type PROCEDURE

Control

not receive any nerve block

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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maha abou-zeid

Assistant Professor of Anesthesia and Surgical Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maha Ahmed AboZeid

Al Mansurah, Mansoura, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Maha A AboZeid, MD

Role: CONTACT

02-01019216192

Facility Contacts

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Maha A AboZeid

Role: primary

Other Identifiers

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Jaw nerve block

Identifier Type: -

Identifier Source: org_study_id

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