Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery

Bezmialem Vakif University

Status: Enrolling

Conditions: Sphenopalatine Ganglion Block; Bimaxillar Surgery

Treatments: Procedure: Sham Block; Procedure: Sphenopalatine Ganglion Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06933680

BezmialemVU-AR-BC-01

Details and patient eligibility

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with bimaxillary orthognathic surgery indication
• Patients with American Society of Anesthesiologistsscores (ASA) I-II
• Patients between the ages of 18-45

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

SPG block group

Active Comparator group

Description:

This group will receive a SPG block using 4 ml of 5% bupivacaine after entübastion.

Treatment:

Procedure: Sphenopalatine Ganglion Block

control group

Sham Comparator group

Description:

This group will receive a sham block using the same method using 4 ml of physiological saline after intubation.

Treatment:

Procedure: Sham Block