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NCT Number: NCT06933680

Sphenopalatine Ganglion Block 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:

* 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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Key information

Conditions

Bimaxillar Surgery Edema Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sphenopalatine Ganglion Block

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf Üniversitesi

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Meckel ganglion block, pterygopalatine ganglion block

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Effect of the Block on Temperature

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

    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.

  2. Heart rate

    Time frame: Measurements are taken every 15 minutes preoperatively and throughout the surgery

    Heart rate is monitored and recorded perioperatively using noninvasive monitoring.

  3. Mean arterial pressure

    Time frame: Measurements are taken every 15 minutes preoperatively and throughout the surgery

    Mean arterial pressure is monitored and recorded perioperatively using noninvasive monitoring.

  4. Opioid and Anesthetic Agent Consumption

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

    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.

  5. Quality of the surgical field

    Time frame: That is recorded once at the end of surgery.

    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

  6. Postoperative Analgesic Consumption

    Time frame: These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.

    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.

  7. Mouth Opening

    Time frame: Measurements are taken preoperatively, on postoperative day 1, day 3, and day 7.

    The distance between font teeth is measured and recorded with soft ruler.

  8. Nausea and Vomiting

    Time frame: These assessments are recorded at 30 minutes, 6 hours, postoperative day 1, day 2 and day 3.

    Nausea and vomiting are evaluated using a 4-point categorical scale 0 = No nausea

    • = Nausea only
    • = Nausea with retching
    • = Vomiting

Study contacts

Contact information is provided by the study sponsor or research team.

Büşra Ceylan, Resident Doctor

CONTACT

[email protected]

+905058945208

Harun Uysal, Associate Professor

CONTACT

[email protected]

+905063433494

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

The Effect of Sphenopalatine Ganglion Block on Intraoperative Analgesia, Postoperative Edema, and Pain in Bimaxillary Orthognathic Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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