Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05567497 |
| Other study ID # |
Trigeminal nerve block |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
March 30, 2023 |
Study information
| Verified date |
December 2022 |
| Source |
Suez Canal University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
