Clinical trial NCT06933680: Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery
Official title: The Effect of Sphenopalatine Ganglion Block on Intraoperative Analgesia, Postoperative Edema, and Pain in Bimaxillary Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bimaxillar Surgery
Sphenopalatine Ganglion Block
Keywords: sphenopalatine ganglion block
pain
bimaxillary orthognathic surgery
edema
swelling
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postoperative Edema
timeFrame: Measurements are taken preoperatively, at 24 hours postoperatively, on postoperative day 3, day 7 and at 1 month.
measure: Postoperative Pain
timeFrame: 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:
measure: Effect of the Block on Temperature
timeFrame: Measurements are taken every 5 minutes for the first 1 hour after induction.
measure: Heart rate
timeFrame: Measurements are taken every 15 minutes preoperatively and throughout the surgery
measure: Mean arterial pressure
timeFrame: Measurements are taken every 15 minutes preoperatively and throughout the surgery
measure: Opioid and Anesthetic Agent Consumption
timeFrame: The agents used during surgery are recorded once at the end of anesthesia.
measure: Quality of the surgical field
timeFrame: That is recorded once at the end of surgery.
measure: Postoperative Analgesic Consumption
timeFrame: These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.
measure: Mouth Opening
timeFrame: Measurements are taken preoperatively, on postoperative day 1, day 3, and day 7.
measure: Nausea and Vomiting
timeFrame: These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakıf Üniversitesi
state: Fatih
Study officials:
affiliation: Bezmialem Vakıf Üniversitesi
name: Büşra Ceylan, Resident Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakıf Üniversitesi
name: Harun Uysal, Associate Professor
role: STUDY_DIRECTOR
affiliation: Medipol Acıbadem District Hospital
name: Ayda Türköz, Professor Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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/
citation: 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.