Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery

Summary

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

• Bimaxillar Surgery
• Sphenopalatine Ganglion Block

Interventions

PROCEDURE

Sphenopalatine Ganglion Block

To perform an SPG block, the ultrasound linear probe is placed parallel to the zygomatic bone, facing anteriorly, to obtain an image that includes the ramus of the maxilla and mandible and the pterygoid process of the sphenoid bone. A 23-gauge, 50 mm needle is inserted just behind the posterior orbital rim and advanced in an antero-caudal direction over the zygomatic arch. When the needle reaches the pterygopalatine fossa at approximately 5 cm, aspiration is performed to check for blood. If no blood is seen, 4 mL of 0.5% bupivacaine is injected. The procedure is performed on both sides

PROCEDURE

Sham Block

To perform a Sham block, the ultrasound linear probe is placed parallel to the zygomatic bone, facing anteriorly, to obtain an image that includes the ramus of the maxilla and mandible and the pterygoid process of the sphenoid bone. A 23-gauge, 50 mm needle is inserted just behind the posterior orbital rim and advanced in an antero-caudal direction over the zygomatic arch. When the needle reaches the pterygopalatine fossa at approximately 5 cm, aspiration is performed to check for blood. If no blood is seen, 4 mL of %0,9 NaCl is injected. The procedure is performed on both sides.

Sponsors & Collaborators

• Bezmialem Vakif University

  lead OTHER

Principal Investigators

• Büşra Ceylan, Resident Doctor · Bezmialem Vakıf Üniversitesi

• Harun Uysal, Associate Professor · Bezmialem Vakıf Üniversitesi

• Ayda Türköz, Professor Doctor · Medipol Acıbadem District Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-25

Primary Completion

2025-05-01

Completion

2025-05-15

Countries

• Turkey (Türkiye)

Study Locations