Maxillary and Mandibular Nerve Block (nerve block)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Maxillary and mandibular nerve block; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha A AboZeid, MD; Phone Number: 02-01019216192; Email: mahazed@yahoo.com

Study Locations

• Egypt
  • Mansoura, Egypt, 35511
    • Recruiting
    • Maha Ahmed AboZeid
    • Sub-Investigator: Shimaa A Shalaby, MD
    • Contact: Maha A AboZeid; Email: mahazed@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; receive bilateral combined maxillary and mandibular nerve block
Placebo Comparator: Control (C) group; not receive any nerve block	Other: Control; not receive any nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total postoperative fentanyl rescue analgesic consumption	microgram	first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-cm visual analogue scale (VAS)	where 0 represented no pain, and 10 meant the worst possible pain	at 0, 2, 4, 6, 8, 12, and 24 hours postoperatively
Postoperative analgesic duration	hours	up to 24 hours (the time from ending of the nerve block till the first rescue morphine dose)
Patients' satisfaction about their analgesia	on a scale from 1 (poor), 2 (fair) to 3 (good)	24 hours postoperatively
Intraoperative heart rate (HR)	beats per minute	each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
Intraoperative mean arterial pressure (MAP)	mmHg	each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
Total postoperative diclofenac sodium consumption	mg	24 hours postoperatively
The total Intraoperative supplementary fentanyl	microgram	during the intraoperative duration

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Jaw nerve block

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No