Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery

NCT06933680 | Recruiting

• 1 other identifier: BezmialemVU-AR-BC-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bimaxillar Surgery; Sphenopalatine Ganglion Block

Keywords

sphenopalatine ganglion block; pain; bimaxillary orthognathic surgery; edema; swelling

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

Secondary Outcomes (8)

• Effect of the Block on Temperature

  Measurements are taken every 5 minutes for the first 1 hour after induction.

• Heart rate

  Measurements are taken every 15 minutes preoperatively and throughout the surgery

• Mean arterial pressure

  Measurements are taken every 15 minutes preoperatively and throughout the surgery

• Opioid and Anesthetic Agent Consumption

  The agents used during surgery are recorded once at the end of anesthesia.

• Quality of the surgical field

  That is recorded once at the end of surgery.

Study Arms (2)

SPG block group

ACTIVE COMPARATOR

This group will receive a SPG block using 4 ml of 5% bupivacaine after entübastion.

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.

Procedure: Sham Block

Interventions

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

Also known as: Meckel ganglion block, pterygopalatine ganglion block

SPG block group

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.

control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf Üniversitesi

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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 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.

  PMID: 39880716 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.

  PMID: 31448247 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.

  PMID: 33055565 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.

  PMID: 9831062 BACKGROUND

• 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/

  PMID: 30725629 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.

  PMID: 31678060 BACKGROUND

MeSH Terms

Conditions

Pain; Edema

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Büşra Ceylan, Resident Doctor

  Bezmialem Vakıf Üniversitesi

  PRINCIPAL INVESTIGATOR

• Harun Uysal, Associate Professor

  Bezmialem Vakıf Üniversitesi

  STUDY DIRECTOR

• Ayda Türköz, Professor Doctor

  Medipol Acıbadem District Hospital

  STUDY DIRECTOR

Central Study Contacts

Büşra Ceylan, Resident Doctor

CONTACT

+905058945208; bcalis@bezmialem.edu.tr

Harun Uysal, Associate Professor

CONTACT

+905063433494; drharunuysal@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician in Anesthesiology and Reanimation

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 18, 2025
• Study Start: June 25, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 15, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)