The Effect of Sphenopalatine Ganglion Block on Intraoperative Analgesia, Postoperative Edema, and Pain in Bimaxillary Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative Edema
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bimaxillary orthognathic surgery indication
- •Patients with American Society of Anesthesiologistsscores (ASA) I-II
- •Patients between the ages of 18-45
排除标准
- •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
研究组 & 干预措施
SPG block group
This group will receive a SPG block using 4 ml of 5% bupivacaine after entübastion.
干预措施: Sphenopalatine Ganglion Block (Procedure)
control group
This group will receive a sham block using the same method using 4 ml of physiological saline after intubation.
干预措施: Sham Block (Procedure)
结局指标
主要结局
Postoperative Edema
时间窗: 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
时间窗: 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.
次要结局
- Effect of the Block on Temperature(Measurements are taken every 5 minutes for the first 1 hour after induction.)
- Heart rate(Measurements are taken every 15 minutes preoperatively and throughout the surgery)
- Mean arterial pressure(Measurements are taken every 15 minutes preoperatively and throughout the surgery)
- Opioid and Anesthetic Agent Consumption(The agents used during surgery are recorded once at the end of anesthesia.)
- Quality of the surgical field(That is recorded once at the end of surgery.)
- Postoperative Analgesic Consumption(These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.)
- Mouth Opening(Measurements are taken preoperatively, on postoperative day 1, day 3, and day 7.)
- Nausea and Vomiting(These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.)
研究者
Büşra Ceylan
Resident Physician in Anesthesiology and Reanimation
Bezmialem Vakif University