Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery

Not Applicable

Recruiting

• Conditions: Bimaxillar Surgery; Sphenopalatine Ganglion Block

• Registration Number: NCT06933680
• Lead Sponsor: Bezmialem Vakif University

Brief 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.

Study Timeline

• Study Start: 2024-06-25
• Study First Submitted: 2025-03-27
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Edema	Measurements are taken preoperatively, at 24 hours postoperatively, on postoperative day 3, day 7 and at 1 month.	Using the technique of Gabka and Matsumura, gonion, mentum, and tragus are marked with methylene blue before surgery. The distances between the marks are measured bilaterally in millimeters using a flexible ruler and recorded.; The measurement points will include: * Tragus-labial commissure distance; * Tragus-alar notch distance; * Gonion-lateral canthus distance; * Tragus-mentum distance; Postoperatively, edema measurements are taken from the same points.
Postoperative Pain	The patient's pain at rest and during movement is evaluated at 30 minutes, 6 hours, 12 hours, 24 hours and 48 hours following the end of the surgery.	The numeric rating scale(NRS) is used to evaluate postoperative pain. Patients are asked to rate their pain on the scale of 0 to 10, with 0 indicating no pain and 10 indicating unbearable pain. Nrs scores are recorded.

Secondary Outcome Measures

Name	Time	Method
Effect of the Block on Temperature	Measurements are taken every 5 minutes for the first 1 hour after induction.	Starting before the block, the forehead skin temperature will be recorded every 5 minutes for 1 hour. During this period, the block time and surgical draping time are noted.
Heart rate	Measurements are taken every 15 minutes preoperatively and throughout the surgery	Heart rate is monitored and recorded perioperatively using noninvasive monitoring.
Mean arterial pressure	Measurements are taken every 15 minutes preoperatively and throughout the surgery	Mean arterial pressure is monitored and recorded perioperatively using noninvasive monitoring.
Opioid and Anesthetic Agent Consumption	The agents used during surgery are recorded once at the end of anesthesia.	The amount of sevoflurane required to maintain the bispectral index (BIS) value within the target range and the total remifentanil used are recorded at the end of each patient's surgery.
Quality of the surgical field	That is recorded once at the end of surgery.	The surgeon assesses the quality of the surgical field using a predefined category scale, adapted from Fromme GA et al. at the end of the surgery.; Fromme Scale : * Grade 1: Massive uncontrollable bleeding; * Grade 2: Bleeding, heavy but controllable, that significantly interferes with dissection; * Grade 3: Moderate bleeding that moderately compromises surgical dissection; * Grade 4: Moderate bleeding, a nuisance but without interfering with aaccurate dissection; * Grade 5: Bleeding, so mild it was not even a surgical nuisance; * Grade 6: No bleeding, virtually bloodless field
Postoperative Analgesic Consumption	These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.	As a secondary parameter for pain assessment, the amount of opioid analgesic (tramadol) used, the number of requests and the need for rescue analgesics are recorded through patient-controlled analgesia devices.
Mouth Opening	Measurements are taken preoperatively, on postoperative day 1, day 3, and day 7.	The distance between font teeth is measured and recorded with soft ruler.
Nausea and Vomiting	These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.	Nausea and vomiting are evaluated using a 4-point categorical scale 0 = No nausea; 1. = Nausea only; 2. = Nausea with retching; 3. = Vomiting

Trial Locations

Locations (1)

Bezmialem Vakıf Üniversitesi; 🇹🇷 İstanbul, Fatih, Turkey