Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
NCT06933680

Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery

Led by Bezmialem Vakif University · Updated on 2025-04-18

50

Participants Needed

1

Research Sites

46 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate whether sphenopalatine ganglion (SPG) block helps with intraoperative pain control, reduces postoperative edema, and decreases pain in adults aged 18 to 45 undergoing bimaxillary orthognathic surgery. The main questions it aims to answer are: * Does SPG block help decrease postoperative swelling and pain compared to a sham block? * Does it improve pain control during surgery and reduce opioid use? Researchers will compare patients receiving SPG block to those receiving a sham block to determine if this technique provides better pain relief and reduces postoperative complications. Participants will: * Be 18 to 45 years old and undergo bimaxillary orthognathic surgery. * Be randomly assigned to receive either a SPG block or a sham block before surgery. * Be monitored for 1 month after surgery to assess pain levels, swelling, opioid use, and possible complications.

CONDITIONS

Official Title

Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with bimaxillary orthognathic surgery indication
  • Patients with American Society of Anesthesiologist scores (ASA) I-II
  • Patients between the ages of 18-45
Not Eligible

You will not qualify if you...

  • Patients with local anesthetic allergy
  • Patients undergoing genioplasty
  • Syndromes associated with secondary deformities in addition to jaw deformities
  • Patients with a history of jaw surgery
  • Patients with uncontrolled hypertension
  • Patients with a history of substance abuse
  • Patients with chronic pain lasting more than 3 months
  • Patients using analgesic and hypnotic agents for more than 2 weeks
  • Recent situations that may cause facial edema (tooth extraction, facial trauma, etc.)
  • Patients with psychiatric disorders
  • Patients with diabetes mellitus
  • Patients with bleeding disorders

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Bezmialem Vakıf Üniversitesi

Istanbul, Fatih, Turkey (Türkiye), 34093

Actively Recruiting

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Research Team

B

Büşra Ceylan, Resident Doctor

CONTACT

H

Harun Uysal, Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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