Effect of Bilateral Maxillary Block on Intraoperative Remifentanil Consumption

NCT07608861 | Recruiting

• 1 other identifier: AEŞH-EK-32
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Septorhinoplasty; Remifentanil Consumption; Maxillary Block

Outcome Measures

Primary Outcomes (1)

• Intraoperative remifentanil consumption

  The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.

  Intraoperative period

Secondary Outcomes (3)

• Mean arterial pressure

  Intraoperative period

• Heart rate

  Intraoperative period

• Pain scores

  First 24 hours after surgery

Study Arms (2)

Preoperative Maxillary Block

ACTIVE COMPARATOR

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.

Drug: Preoperative Maxillary Block

Postoperative Maxillary Block

ACTIVE COMPARATOR

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.

Drug: Postoperative Maxillary Block

Interventions

Preoperative Maxillary Block DRUG

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.

Preoperative Maxillary Block

Postoperative Maxillary Block DRUG

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.

Postoperative Maxillary Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old
• American Society of Anesthesiologists (ASA) physical status I-II
• Body mass index 18 to 30 kg/m2
• Septorhinoplasty surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Musa Zengin, Associate Professor

CONTACT

05307716235; musazengin@gmail.com

Mücahit Yılmaz, Medical Doctor

CONTACT

00905366840479; dr.mucahitosman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-06

Locations

TU (1)