Sphenopalatine Ganglion Block in Bimaxillary Orthognathic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBezmialem Vakif University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with bimaxillary orthognathic surgery indication
Patients with American Society of Anesthesiologistsscores (ASA) I-II
Patients between the ages of 18-45
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sphenopalatine Ganglion Block
Procedure/SurgeryTo 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
Procedure/SurgeryTo 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: SPG block groupActive comparator 1 intervention
Group B: control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Measurements are taken preoperatively, at 24 hours postoperatively, on postoperative day 3, day 7 and at 1 month.2
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.
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.Secondary outcomes
1
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.
Time frame
Measurements are taken every 5 minutes for the first 1 hour after induction.2
Heart rate
Heart rate is monitored and recorded perioperatively using noninvasive monitoring.
Time frame
Measurements are taken every 15 minutes preoperatively and throughout the surgery3
Mean arterial pressure
Mean arterial pressure is monitored and recorded perioperatively using noninvasive monitoring.
Time frame
Measurements are taken every 15 minutes preoperatively and throughout the surgery4
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.
Time frame
The agents used during surgery are recorded once at the end of anesthesia.Sponsors and contacts
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Source ClinicalTrials.gov