- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07608861
Effect of Bilateral Maxillary Block on Intraoperative Remifentanil Consumption
June 1, 2026 updated by: Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Effect of Bilateral Maxillary Block on Intraoperative Remifentanil Consumption in Septorhinoplasty Surgery
The maxillary nerve block is a regional anesthetic technique targeting the sensory distribution of the maxillary nerve and is particularly preferred to provide analgesia in midfacial and maxillary surgical procedures.
It has been used to optimize perioperative and postoperative pain control, reduce intraoperative opioid requirements, and support hemodynamic stability in procedures including septorhinoplasty, nasal bone osteotomies, nasal valve surgery, and endoscopic sinus surgery.
This study aimed to compare the effects of the timing of bilateral maxillary nerve block administration (post-intubation vs. pre-extubation) on intraoperative remifentanil consumption and postoperative analgesia in patients undergoing septorhinoplasty.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Musa Zengin, Associate Professor
- Phone Number: 05307716235
- Email: musazengin@gmail.com
Study Contact Backup
- Name: Mücahit Yılmaz, Medical Doctor
- Phone Number: 00905366840479
- Email: dr.mucahitosman@gmail.com
Study Locations
-
-
Ankara
-
Yenimahalle, Ankara, Turkey (Türkiye), 06170
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- Musa Zengin, Associate Professor
- Phone Number: 00905307716235
- Email: musazengin@gmail.com
-
Contact:
- Mücahit Yılmaz, Medical Doctor
- Phone Number: 00905366840479
- Email: dr.mucahitosman@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II
- Body mass index 18 to 30 kg/m2
- Septorhinoplasty surgery
Exclusion Criteria:
- Patient refusing the procedure
- Patients who have previously undergone nasal surgery
- Chronic opioid or analgesic use
- Patients with allergies to local anesthetics
- Patients with Hypertension
- Patients receiving antihypertensive treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Preoperative Maxillary Block
After the intubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa.
Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions.
A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle.
The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique.
After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side.
The same procedure will subsequently be repeated contralaterally.
|
After the intubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa.
Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions.
A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle.
The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique.
After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side.
The same procedure will subsequently be repeated contralaterally.
|
|
Active Comparator: Postoperative Maxillary Block
At the end of the surgery, before the extubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa.
Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions.
A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle.
The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique.
After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side.
The same procedure will subsequently be repeated contralaterally.
|
At the end of the surgery, before the extubation, the block procedure will be performed under ultrasound guidance using an infrazygomatic approach to access the pterygopalatine fossa.
Prior to the procedure, the cheek region will be prepared in accordance with aseptic conditions.
A linear ultrasound probe will be positioned over the infrazygomatic area to visualize the maxillary tuberosity, lateral pterygoid plate, coronoid process, and mandibular condyle.
The following image optimization using the jaw-opening maneuver, the maxillary artery will be identified as an anatomical landmark, and a 50-mm block needle will be advanced into the pterygopalatine fossa using an in-plane technique.
After confirmation of negative aspiration, a total of 4 mL of local anesthetic solution consisting of 2 mL of 0.5% bupivacaine and 2 mL of 2% lidocaine (Aritmal) will be injected on each side.
The same procedure will subsequently be repeated contralaterally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative remifentanil consumption
Time Frame: Intraoperative period
|
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.
|
Intraoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scores
Time Frame: First 24 hours after surgery
|
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain assessment will be done at the 1st, 2nd, 6th, 12th, and 24th hours after surgery.
|
First 24 hours after surgery
|
|
Mean arterial pressure
Time Frame: Intraoperative period
|
Mean arterial pressure values will be recorded before anesthesia, before surgical incision, after surgical incision at the 5th, 30th, 60th, 90th, 120th, 150th, 180th, and 210th minutes, and after general anesthesia.
|
Intraoperative period
|
|
Heart rate
Time Frame: Intraoperative period
|
Heart rate values will be recorded before anesthesia, before surgical incision, after surgical incision at the 5th, 30th, 60th, 90th, 120th, 150th, 180th, and 210th minutes, and after general anesthesia.
|
Intraoperative period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 20, 2026
Study Registration Dates
First Submitted
May 20, 2026
First Submitted That Met QC Criteria
May 20, 2026
First Posted (Actual)
May 27, 2026
Study Record Updates
Last Update Posted (Actual)
June 2, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- AEŞH-EK-32
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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