Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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

Первичные конечные точки

• Postoperative Edema [Срок оценки: Measurements are taken preoperatively, at 24 hours postoperatively, on postoperative day 3, day 7 and at 1 month.]
• Postoperative Pain [Срок оценки: 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.]

Вторичные конечные точки (8)

• Effect of the Block on Temperature [Срок оценки: Measurements are taken every 5 minutes for the first 1 hour after induction.]
• Heart rate [Срок оценки: Measurements are taken every 15 minutes preoperatively and throughout the surgery]
• Mean arterial pressure [Срок оценки: Measurements are taken every 15 minutes preoperatively and throughout the surgery]
• Opioid and Anesthetic Agent Consumption [Срок оценки: The agents used during surgery are recorded once at the end of anesthesia.]
• Quality of the surgical field [Срок оценки: That is recorded once at the end of surgery.]
• Postoperative Analgesic Consumption [Срок оценки: These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.]
• Mouth Opening [Срок оценки: Measurements are taken preoperatively, on postoperative day 1, day 3, and day 7.]
• Nausea and Vomiting [Срок оценки: These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Bezmialem Vakıf Üniversitesi — Istanbul

Публикации

• Smith CR, Dickinson KJ, Carrazana G, Beyer A, Spana JC, Teixeira FJP, Zamajtuk K, Maciel CB, Busl KM. Ultrasound-Guided Suprazygomatic Nerve Blocks to the Pterygopalatine Fossa: A Safe Procedure. Pain Med. 2022 Aug 1;23(8):1366-1375. doi: 10.1093/pm/pnac007. PMID 35043949
• Sumphaongern T, Chantarangsu S. Effect of Dexmedetomidine on Blood Loss and Patient Outcomes in Orthognathic Surgery: A Randomised Clinical Trial. Int Dent J. 2025 Jun;75(3):1961-1969. doi: 10.1016/j.identj.2025.01.009. Epub 2025 Jan 28. PMID 39880716
• Keyhan SO, Fallahi HR, Cheshmi B, Mokhtari S, Zandian D, Yousefi P. Use of piezoelectric surgery and Er:YAG laser:which one is more effective during impacted third molar surgery? Maxillofac Plast Reconstr Surg. 2019 Aug 6;41(1):29. doi: 10.1186/s40902-019-0212-6. eCollection 2019 Dec. PMID 31448247
• Sari N, Uysal E. Endoscopic Sphenopalatine Ganglion Block Efficacy in the Management of Periorbital Edema and Ecchymosis After Septorhinoplasty. J Craniofac Surg. 2021 May 1;32(3):983-987. doi: 10.1097/SCS.0000000000007189. PMID 33055565
• Robiony M, Demitri V, Costa F, Politi M, Cugini U. Truncal anaesthesia of the maxillary nerve for outpatient surgically assisted rapid maxillary expansion. Br J Oral Maxillofac Surg. 1998 Oct;36(5):389-91. doi: 10.1016/s0266-4356(98)90653-2. PMID 9831062
• Shah RJ, Dixon B, Padalia D. Sphenopalatine Ganglion Radiofrequency Thermocoagulation. 2023 Jul 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536944/ PMID 30725629
• Dominguez Camacho A, Velasquez SA, Benjumea Marulanda NJ, Moreno M. Photobiomodulation as oedema adjuvant in post-orthognathic surgery patients: A randomized clinical trial. Int Orthod. 2020 Mar;18(1):69-78. doi: 10.1016/j.ortho.2019.09.004. Epub 2019 Oct 31. PMID 31678060

Идентификаторы

NCT: NCT06933680 · BezmialemVU-AR-BC-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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