Maxillary and Mandibular Nerve Block

NCT05925465 | Recruiting

• 1 other identifier: Jaw nerve block
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Total postoperative fentanyl rescue analgesic consumption

  microgram

  first 24 hours postoperatively

Secondary Outcomes (7)

• Intraoperative heart rate (HR)

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

• Intraoperative mean arterial pressure (MAP)

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

• 10-cm visual analogue scale (VAS)

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

• Postoperative analgesic duration

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

• Patients' satisfaction about their analgesia

  24 hours postoperatively

Study Arms (2)

Maxillary and mandibular nerve block (MMNB) group

ACTIVE COMPARATOR

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

Control (C) group

PLACEBO COMPARATOR

not receive any nerve block

Other: Control

Interventions

Maxillary and mandibular nerve block PROCEDURE

receive bilateral combined maxillary and mandibular nerve block

Maxillary and mandibular nerve block (MMNB) group

Control OTHER

not receive any nerve block

Control (C) group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) I/II patients,
• within the age group of 21-60 years
• both sex
• scheduled for elective faciomaxillary surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Maha Ahmed AboZeid

Al Mansurah, Mansoura, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maha A AboZeid, MD

CONTACT

02-01019216192; mahazed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Nerve block will be done by an anesthesiologist who will not be involved in data collection to ensure blindness.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Surgical Intensive Care

Model Details: 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)

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

EG (1)