Maxillary and Mandibular Nerve Block

Analgesia Clinical Trial

— nerve block  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925465
• Other study ID #: Jaw nerve block
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Mansoura University
• Contact: Maha A AboZeid, MD
• Phone: 02-01019216192
• Email: mahazed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• Maxillary and mandibular nerve block
receive bilateral combined maxillary and mandibular nerve block

Other:
• Control
not receive any nerve block

Locations

Country	Name	City	State
Egypt	Maha Ahmed AboZeid	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total postoperative fentanyl rescue analgesic consumption	microgram	first 24 hours postoperatively
Secondary	Intraoperative heart rate (HR)	beats per minute	each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
Secondary	Intraoperative mean arterial pressure (MAP)	mmHg	each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
Secondary	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
Secondary	Postoperative analgesic duration	hours	up to 24 hours (the time from ending of the nerve block till the first rescue morphine dose)
Secondary	Patients' satisfaction about their analgesia	on a scale from 1 (poor), 2 (fair) to 3 (good)	24 hours postoperatively
Secondary	Total postoperative diclofenac sodium consumption	mg	24 hours postoperatively
Secondary	The total Intraoperative supplementary fentanyl	microgram	during the intraoperative duration