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Effect of Bilateral Maxillary Block on Intraoperative Remifentanil Consumption

1. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Tyrkia (Türkiye)
    • Ankara
      • Yenimahalle, Ankara, Tyrkia (Türkiye), 06170
        • Rekruttering
        • Ankara Etlik City Hospital
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Legemiddel: 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.
Aktiv komparator: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intraoperative remifentanil consumption
Tidsramme: Intraoperative period
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.
Intraoperative period

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Smerte scorer
Tidsramme: Første 24 timer etter operasjonen
Smerte vil bli vurdert i hvile og ved hoste ved å bruke den visuelle analoge skalaen på en skala fra 0 (ingen smerte) til 10 (verste smerte). Smertevurdering vil bli gjort 1., 2., 6., 12. og 24. time etter operasjonen.
Første 24 timer etter operasjonen
Mean arterial pressure
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

20. desember 2026

Datoer for studieregistrering

Først innsendt

20. mai 2026

Først innsendt som oppfylte QC-kriteriene

20. mai 2026

Først lagt ut (Faktiske)

27. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • AEŞH-EK-32

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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