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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPG block group | Active Comparator | This group will receive a SPG block using 4 ml of 5% bupivacaine after entübastion. |
|
| control group | Sham Comparator | This group will receive a sham block using the same method using 4 ml of physiological saline after intubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphenopalatine Ganglion Block | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Edema | 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:
Postoperatively, edema measurements are taken from the same points. | Measurements are taken preoperatively, at 24 hours postoperatively, on postoperative day 3, day 7 and at 1 month. |
| Postoperative Pain | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the Block on Temperature | 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. | Measurements are taken every 5 minutes for the first 1 hour after induction. |
| Heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Büşra Ceylan, Resident Doctor | Contact | +905058945208 | bcalis@bezmialem.edu.tr | |
| Harun Uysal, Associate Professor | Contact | +905063433494 | drharunuysal@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Büşra Ceylan, Resident Doctor | Bezmialem Vakıf Üniversitesi | Principal Investigator |
| Harun Uysal, Associate Professor | Bezmialem Vakıf Üniversitesi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakıf Üniversitesi | Recruiting | Istanbul | Fatih | 34093 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35043949 | Background | 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. | |
| 39880716 | Background | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D004487 | Edema |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
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For the study's randomization, 50 sealed envelopes were prepared. Inside, 25 envelopes were labeled "SPG group" and 25 were labeled "control group." One sealed envelope is randomly selected and given to the anesthesia technician.
The anesthesia technician prepares either Marcaine or saline solution for the block and hands it to the anesthesiologist without revealing its contents. The anesthesia technician also assigns a number to each patient based on their registration order and records the patient's group in a confidential list.
The anesthesiologist, who is blinded to the group assignments, performs the block and monitors the patient, records. The surgical team, also blinded, evaluates surgical comfort. Patients remain blinded to their group during follow-ups.
At the end of the study, patient data will be matched with their assigned groups for analysis.
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|
| Sham Block | Procedure | 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. |
|
Heart rate is monitored and recorded perioperatively using noninvasive monitoring. |
| Measurements are taken every 15 minutes preoperatively and throughout the surgery |
| Mean arterial pressure | Mean arterial pressure is monitored and recorded perioperatively using noninvasive monitoring. | Measurements are taken every 15 minutes preoperatively and throughout the surgery |
| Opioid and Anesthetic Agent Consumption | 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. | The agents used during surgery are recorded once at the end of anesthesia. |
| Quality of the surgical field | 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 :
| That is recorded once at the end of surgery. |
| Postoperative Analgesic Consumption | 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. | These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3. |
| Mouth Opening | The distance between font teeth is measured and recorded with soft ruler. | Measurements are taken preoperatively, on postoperative day 1, day 3, and day 7. |
| Nausea and Vomiting | Nausea and vomiting are evaluated using a 4-point categorical scale 0 = No nausea
| These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3. |
| Ayda Türköz, Professor Doctor |
| Medipol Acıbadem District Hospital |
| Study Director |
| 31448247 | Background | 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. |
| 33055565 | Background | 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. |
| 9831062 | Background | 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. |
| 30725629 | Background | 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/ |
| 31678060 | Background | 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. |
| D000760 |
| Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |