NCT06933680

Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery

The Effect of Sphenopalatine Ganglion Block on Intraoperative Analgesia, Postoperative Edema, and Pain in Bimaxillary Orthognathic Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Orthognathic surgery is a procedure used to correct jaw bone problems that are present from birth or develop over time. During this surgery, multiple cuts, tissue separation, and bone reshaping (osteotomy) are done on the upper and lower jaw. After the surgery, the body responds with an inflammatory reaction, causing edema and pain. As the tissues heal, the edema and pain gradually decrease. Edema is a common result of orthognathic surgery and can affect recovery time, return to normal activities, and hospital stay. Research shows that reducing edema can improve a patient's quality of life. Excessive edema can also cause pain and discomfort. To manage this, treatments such as steroids, laser therapy, lymphatic drainage massage, and cold applications are used. The SPG is a nerve center that contains both sensory and autonomic nerve fibers. It connects to the trigeminal nerve, facial nerve, internal carotid plexus, and superior cervical ganglion. The SPG plays a role in widening brain blood vessels, providing sensation to the soft palate, tonsils, upper lip, and mouth floor, and controlling tear gland secretions. In our study, it is anticipated that SPG block may help prevent intraoperative abnormal hemodynamic changes (by facilitating the control of heart rate and mean arterial pressure), reduce bleeding, decrease anesthetic drug consumption, lower the incidence of postoperative nausea and vomiting, and improve postoperative pain control and edema reduction. As a result, the postoperative comfort of patients undergoing orthognathic surgery can be enhanced with a cost-effective and easily applicable method, potentially reducing the risk of chronic pain in the long term. Additionally, by minimizing surgery-related edema and jaw muscle spasms, patients may achieve an optimal quality of life more quickly. Due to the limited number of studies on this technique in oral and maxillofacial surgery, our study is expected to pave the way for future research in this area.

Conditions

• Bimaxillar Surgery
• Sphenopalatine Ganglion Block

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-25
• Primary completion: 2025-05-01
• Completion: 2025-05-15
• First posted: 2025-04-18
• Last updated: 2025-04-18

Locations

1 site across 1 country: Turkey (Türkiye)