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Ultrasound Guided Trigeminal Nerve Block in Maxillofacial Surgeries

Primary Purpose

Maxillofacial Injuries

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
trigeminal nerve block
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillofacial Injuries

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Suez Canal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Trigeminal Nerve Block (TNB)

control

Arm Description

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

patients will receive general anesthesia only (Control Group).

Outcomes

Primary Outcome Measures

total fentanyl consumption during the intraoperative period.
the amount of the fentanyl that will be used intraoperatively as analgesia

Secondary Outcome Measures

Full Information

First Posted
September 25, 2022
Last Updated
December 29, 2022
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT05567497
Brief Title
Ultrasound Guided Trigeminal Nerve Block in Maxillofacial Surgeries
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillofacial Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trigeminal Nerve Block (TNB)
Arm Type
Active Comparator
Arm Description
patients will receive general anesthesia followed 5 ml of 0.25% Bupivacaine for TGB under USG after induction of anesthesia (Block Group).
Arm Title
control
Arm Type
No Intervention
Arm Description
patients will receive general anesthesia only (Control Group).
Intervention Type
Procedure
Intervention Name(s)
trigeminal nerve block
Intervention Description
ultrasound guided trigeminal nerve block
Primary Outcome Measure Information:
Title
total fentanyl consumption during the intraoperative period.
Description
the amount of the fentanyl that will be used intraoperatively as analgesia
Time Frame
immediately at the end of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American society of anesthesia (ASA) criteria I/II Scheduled for elective unilateral maxillo-facial surgery Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrhman Alshawadfy, MD
Organizational Affiliation
Suez Canal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suez Canal University
City
Ismailia
ZIP/Postal Code
2685
Country
Egypt

12. IPD Sharing Statement

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Ultrasound Guided Trigeminal Nerve Block in Maxillofacial Surgeries

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