Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery
NCT ID: NCT06933680
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-06-25
2025-05-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
TRIPLE
Study Groups
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SPG block group
This group will receive a SPG block using 4 ml of 5% bupivacaine after entübastion.
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 blood is seen, 4 mL of 0.5% bupivacaine is injected.
The procedure is performed on both sides
control group
This group will receive a sham block using the same method using 4 ml of physiological saline after intubation.
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 blood is seen, 4 mL of %0,9 NaCl is injected.
The procedure is performed on both sides.
Interventions
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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 blood is seen, 4 mL of 0.5% bupivacaine is injected.
The procedure is performed on both sides
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 blood is seen, 4 mL of %0,9 NaCl is injected.
The procedure is performed on both sides.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with American Society of Anesthesiologistsscores (ASA) I-II
* Patients between the ages of 18-45
Exclusion Criteria
* 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
18 Years
45 Years
ALL
No
Sponsors
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Bezmialem Vakif University
OTHER
Responsible Party
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Büşra Ceylan
Resident Physician in Anesthesiology and Reanimation
Principal Investigators
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Büşra Ceylan, Resident Doctor
Role: PRINCIPAL_INVESTIGATOR
Bezmialem Vakıf Üniversitesi
Harun Uysal, Associate Professor
Role: STUDY_DIRECTOR
Bezmialem Vakıf Üniversitesi
Ayda Türköz, Professor Doctor
Role: STUDY_DIRECTOR
Medipol Acıbadem District Hospital
Locations
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Bezmialem Vakıf Üniversitesi
Istanbul, Fatih, Turkey (Türkiye)
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
Shah RJ, Dixon B, Padalia D. Sphenopalatine Ganglion Radiofrequency Thermocoagulation. 2023 Jul 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536944/
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.
Other Identifiers
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BezmialemVU-AR-BC-01
Identifier Type: -
Identifier Source: org_study_id
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