Bimaxillar SurgeryNCT06933680
Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery
A study testing Sphenopalatine Ganglion Block in people with Bimaxillar Surgery and Sphenopalatine Ganglion Block, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bimaxillar Surgery, Sphenopalatine Ganglion Block
- What is being tested?
- Sphenopalatine Ganglion Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with bimaxillary orthognathic surgery indication
- Patients with American Society of Anesthesiologistsscores (ASA) I-II
- Patients between the ages of 18-45
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakıf Üniversitesi
Istanbul, Fatih, 34093
About this study
Official title: The Effect of Sphenopalatine Ganglion Block on Intraoperative Analgesia, Postoperative Edema, and Pain in Bimaxillary Orthognathic Surgery
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:
Read more
- 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.
Read the 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.
- Conditions
- Bimaxillar Surgery, Sphenopalatine Ganglion Block
- Being tested
- Sphenopalatine Ganglion Block, Sham Block
- Keywords
- sphenopalatine ganglion block, pain, bimaxillary orthognathic surgery, edema, swelling
- Medical subject headings
- Pain, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion BlockProcedure or surgery
Also called Meckel ganglion block, pterygopalatine 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 BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| SPG block group | Active comparator | This group will receive a SPG block using 4 ml of 5% bupivacaine after entübastion. Receives: Procedure: Sphenopalatine Ganglion Block |
| control group | Sham comparator | This group will receive a sham block using the same method using 4 ml of physiological saline after intubation. Receives: Procedure: Sham Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Tragus-labial commissure distance
- Tragus-alar notch distance
- Gonion-lateral canthus distance
- Tragus-mentum distance
Postoperatively, edema measurements are taken from the same points.
Measured: 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.
Measured: 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.
Secondary outcomes (8)
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.
Measured: Measurements are taken every 5 minutes for the first 1 hour after induction.
Heart rate
Heart rate is monitored and recorded perioperatively using noninvasive monitoring.
Measured: 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.
Measured: 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.
Measured: 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 :
- 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
Measured: 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.
Measured: 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.
Measured: 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
- = Nausea only
- = Nausea with retching
- = Vomiting
Measured: These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start25 Jun 2024
- Primary completion1 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bimaxillar SurgeryStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Ceylan, Bezmialem Vakif University
- Investigators
- Büşra Ceylan, Resident Doctor, Principal investigator, Bezmialem Vakıf ÜniversitesiHarun Uysal, Associate Professor, Study director, Bezmialem Vakıf ÜniversitesiAyda Türköz, Professor Doctor, Study director, Medipol Acıbadem District Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933680
- Sponsor's protocol ID
- BezmialemVU-AR-BC-01
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35043949Sumphaongern 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.
PubMed 39880716Keyhan 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.
PubMed 31448247Sari 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.
PubMed 33055565Robiony 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.
PubMed 9831062Shah 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/
PubMed 30725629Dominguez 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.
PubMed 31678060
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sphenopalatine Ganglion Block on Intraoperative Analgesia, Postoperative Edema, and Pain in Bimaxillary Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT06933680
- Acronym / sponsor ID
- BezmialemVU-AR-BC-01
- Conditions
- Bimaxillar Surgery, Sphenopalatine Ganglion Block
- Keywords
- sphenopalatine ganglion block, pain, bimaxillary orthognathic surgery, edema, swelling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SPG block group | Active comparator | Procedure: Sphenopalatine Ganglion BlockThis group will receive a SPG block using 4 ml of 5% bupivacaine after entübastion. |
| control group | Sham comparator | Procedure: Sham BlockThis group will receive a sham block using the same method using 4 ml of physiological saline after intubation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with bimaxillary orthognathic surgery indication
- Patients with American Society of Anesthesiologistsscores (ASA) I-II
- Patients between the ages of 18-45
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sphenopalatine Ganglion BlockAlso: Meckel ganglion block, pterygopalatine ganglion blockTo 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 | Procedure or surgery | SPG block group |
| Sham BlockTo 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. | Procedure or surgery | control group |
Primary outcome
Postoperative Edema
Time frame: 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
Time frame: 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.
8 secondary outcomes
Effect of the Block on Temperature
Time frame: Measurements are taken every 5 minutes for the first 1 hour after induction.
Heart rate
Time frame: Measurements are taken every 15 minutes preoperatively and throughout the surgery
Mean arterial pressure
Time frame: Measurements are taken every 15 minutes preoperatively and throughout the surgery
Opioid and Anesthetic Agent Consumption
Time frame: The agents used during surgery are recorded once at the end of anesthesia.
Quality of the surgical field
Time frame: That is recorded once at the end of surgery.
Postoperative Analgesic Consumption
Time frame: These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.
Mouth Opening
Time frame: Measurements are taken preoperatively, on postoperative day 1, day 3, and day 7.
Nausea and Vomiting
Time frame: These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Background: PubMed 35043949Smith 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.
- Background: PubMed 39880716Sumphaongern 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.
- Background: PubMed 31448247Keyhan 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.
- Background: PubMed 33055565Sari 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.
- Background: PubMed 9831062Robiony 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.
- Background: PubMed 30725629Shah 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/
- Background: PubMed 31678060Dominguez 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Büşra Ceylan, Resident Doctor principal investigator
Bezmialem Vakıf Üniversitesi
Harun Uysal, Associate Professor study director
Bezmialem Vakıf Üniversitesi
Ayda Türköz, Professor Doctor study director
Medipol Acıbadem District Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sphenopalatine Ganglion Block in people with Bimaxillar Surgery and Sphenopalatine Ganglion Block, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Büşra Ceylan, Resident Doctor (+905058945208, bcalis@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Edema (time frame: Measurements are taken preoperatively, at 24 hours postoperatively, on postoperative day 3, day 7 and at 1 month.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06933680, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.