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CompletedNCT05567497

Ultrasound Guided Trigeminal Nerve Block in Maxillofacial Surgeries

Evaluating the Perioperative Analgesic Effect of Ultrasound-guided Trigeminal Nerve Block in Adult Patients Undergoing Maxillo-facial Surgery Under General Anesthesia: A Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Suez Canal University · Academic / Other
Sex
All
Age
21 Years – 60 Years
Healthy volunteers
Not accepted

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.

Detailed description

Nerve block using various agents has been proposed as a part of the multimodal analgesia to decrease consumption of intravenous opioids and also decrease its complications such as respiratory depression. Recent research has focused on the role of trigeminal nerve blocks (TNB) for management of facial pain . This block was found to be effective in trigeminalneuralgia , palate surgeries and oral and dental surgeries. Anatomically, the Gasserian ganglion lies in the middle cranial fossa within the Meckel's cave and gives rise to three branches (1) ophthalmic, (2) maxillary, and (3) mandibular which exit from skull through three distinct foramina: the superior orbital fissure, the foramen rotundum, and the foramen ovale. The injection anterior and medial to lateral pterygoid plate into the upper part of pterygopalatine fossa (PPF) will place the injectate in close vicinity to foramen rotundum from where drug migrates into the middle cranial fossa. Since the PPF is extremely vascular, visualizing vascular and soft tissue structures in real time minimize the potential inadvertent complications. Fluoroscopy-guided blocks have long been considered the gold standard practice in head and neck pain management. Alternatively, computed tomography-guided procedures provide a useful option but expensive and have radiation hazard. Lately, ultrasonography (USG) has been used extensively for perioperative pain relief providing excellent visualization of soft tissue and vasculature with real-time needle placement. To date, very few published studies had evaluated the value of USG-guided TNB for control of perioperative pain in maxillofacial surgery.

Conditions

Interventions

TypeNameDescription
PROCEDUREtrigeminal nerve blockultrasound guided trigeminal nerve block

Timeline

Start date
2022-11-01
Primary completion
2023-02-28
Completion
2023-03-30
First posted
2022-10-05
Last updated
2025-04-30

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05567497. Inclusion in this directory is not an endorsement.

Ultrasound Guided Trigeminal Nerve Block in Maxillofacial Surgeries (NCT05567497) · Clinical Trials Directory