Maxillary and Mandibular Nerve Block

Not Applicable

Recruiting

• Conditions: Analgesia
• Interventions: Procedure: Maxillary and mandibular nerve block; Other: Control

• Registration Number: NCT05925465
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-06-29
• Study Start: 2023-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-12-28
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maxillary and mandibular nerve block (MMNB) group	Maxillary and mandibular nerve block	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.
Control (C) group	Control	not receive any nerve block

Primary Outcome Measures

Name	Time	Method
Total postoperative fentanyl rescue analgesic consumption	first 24 hours postoperatively	microgram

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maha Ahmed AboZeid; 🇪🇬 Mansoura, Egypt