Ultrasound Guided Trigeminal Nerve Block in Maxillofacial Surgeries

NCT05567497 | Completed

• 1 other identifier: Trigeminal nerve block
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the perioperative analgesic effect of USG Trigeminal Nerve Block in adult patients undergoing maxillofacial surgery. We hypothesized that giving USG-guided TNB in patients undergoing maxilla-facial surgery could reduce the requirements of opioids perioperatively and avoid the side effects of opioids used. The aim of this double-blind study is to evaluate the effect of USG-guided TNB intra- and post-operatively in terms of pain relief, opioid consumption and adverse effects in patients undergoing such elective surgeries.

Conditions

Maxillofacial Injuries

Outcome Measures

Primary Outcomes (1)

• total fentanyl consumption during the intraoperative period.

  the amount of the fentanyl that will be used intraoperatively as analgesia

  immediately at the end of the surgery

Study Arms (2)

Trigeminal Nerve Block (TNB)

ACTIVE COMPARATOR

patients will receive general anesthesia followed 5 ml of 0.25% Bupivacaine for TGB under USG after induction of anesthesia (Block Group).

Procedure: trigeminal nerve block

control

NO INTERVENTION

patients will receive general anesthesia only (Control Group).

Interventions

trigeminal nerve block PROCEDURE

ultrasound guided trigeminal nerve block

Trigeminal Nerve Block (TNB)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American society of anesthesia (ASA) criteria I/II
• Scheduled for elective unilateral maxillo-facial surgery

You may not qualify if:

• Patients with polytrauma and fracture base of skull.
• Patients with known allergy to the study drugs.
• Patients with coagulopathy.
• Patients with infection at puncture site.
• Patients necessitating postoperative ventilation from the start, since it will be difficult to assess respiratory depression and postoperative pain.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 2685, Egypt

Location

MeSH Terms

Conditions

Maxillofacial Injuries

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Abdelrhman Alshawadfy, MD

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 5, 2022
• Study Start: November 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 30, 2023
• Last Updated: April 30, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)