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Sphenopalatine Ganglion Block as Adjuvant to General Anesthesia Regarding the Quality of Surgical Field in Trans-Sphenoidal Endoscopic Hypophysectomy

29. april 2026 opdateret af: Nada Ashraf Mohamed Fathy, Cairo University

The Efficacy of Ultrasound Guided Sphenopalatine Ganglion Block as Adjuvant to General Anesthesia Regarding the Quality of Surgical Field in Trans-Sphenoidal Endoscopic Hypophysectomy: A Randomized Controlled Trial

This study aims to evaluate the efficacy of ultrasound guided sphenopalatine ganglion block (SPGB) through the suprazygomatic approach in optimizing the quality of surgical field as well as its effect on postoperative pain relief in patients undergoing transsphenoidal pituitary surgeries under general anesthesia.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The main surgical treatment for pituitary adenomas is endoscopic trans-sphenoidal hypophysectomy.

Among the many regional blocks used is the sphenopalatine ganglion block (SPGB). It is one of the parasympathetic ganglia in the head, located in the pterygopalatine fossa, posterior to the middle nasal turbinate, 1-5 mm deep to the mucosa, anterior to the pterygoid canal and lateral to the sphenopalatine foramen.

This superficial location makes it easy to block the ganglion transnasally by topical anesthesia or by injection through many approaches including transnasal, intraoral, infrazygomatic and suprazygomatic approaches.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
      • Cairo, Egypten, 12613
        • Rekruttering
        • Cairo University
        • Kontakt:
        • Underforsker:
          • Khaled Alshafei, MD
        • Underforsker:
          • Safinaz H Osman, MD
        • Underforsker:
          • Mohamed Farid, MD
        • Underforsker:
          • Maged Gamal, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age between 21 and 60 years.
  • American Society of Anesthesiologists (ASA) Physical Status I or II.
  • Undergoing elective endoscopic trans-nasal resection of pituitary adenoma.

Exclusion Criteria:

  • Patient's refusal
  • ASA Physical Status III or IV patients
  • Patients receiving drugs influencing blood coagulation
  • Allergy to any of the drugs utilized in this study
  • History of chronic pain therapy
  • Inadvertent intra-operative vascular injury

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A
Patients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone .
Medicin: Sphenopalatine ganglion block using bupivacaine + dexamethasone
Patients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone.
Aktiv komparator: Group B
Patients will receive general anesthesia alone.
Andet: General anesthesia
Patients will receive general anesthesia alone.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of surgical field visibility
Tidsramme: Intraoperatively

Quality of surgical field visibility will be measured at the beginning of surgery and at 30 mins interval through a pre-defined average category scale (ACS) (from 0 to 5). The ideal category scale values for surgical conditions were pre-determined to be ≤3.

0=No bleeding

  1. Slight bleeding - no suctioning of blood required
  2. Slight bleeding - occasional suctioning required. Surgical field not threatened
  3. Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed
  4. Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed
  5. Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible
Intraoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative fentanyl consumption
Tidsramme: Intraoperatively
The hemodynamic objective of the anesthetic plan is to maintain mean arterial pressure values between 60 mmHg and 65 mmHg to produce an optimal surgical field, this will be done by injection of increments of fentanyl (0.5 μg/kg) up to total dose of 3 μg/kg
Intraoperatively
Total dose of propranolol
Tidsramme: Intraoperatively
In case of reflex persistent increase in heart rate (HR) >100 beats/min, i.v. 0.2 mg increments of propranolol will be given to maintain HR 60-70 beats/min.
Intraoperatively
Total dose of nitroglycerine
Tidsramme: Intraoperatively
In case of reduction of mean arterial pressure (MAP), nitroglycerine infusion will be done through adjustment from 0.5 to 10 μg/kg/ min according to patient response.
Intraoperatively
Amount of intraoperative blood loss
Tidsramme: Intraoperatively
Amount of intraoperative blood loss (by measuring the volume of blood in suction reservoir minus the normal saline used to wash the surgical field)
Intraoperatively
Degree of pain
Tidsramme: 24 hours postoperatively
Each patient will be instructed about postoperative pain assessment with visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be measured immediately after the operation, then at 2, 12, and 24hrs.
24 hours postoperatively
Time of 1st analgesia requirement
Tidsramme: 24 hours postoperatively
Postoperative analgesia is performed with administration of paracetamol/acetaminophen (1 g three times a day) and visual analog scale (VAS) ≥4 will be managed by IV dose of 25mg pethidine.
24 hours postoperatively
Total meperidine consumption
Tidsramme: 24 hours postoperatively
Total postoperative meperidine consumption will be recorded.
24 hours postoperatively
Incidence of postoperative side effects
Tidsramme: 24 hours postoperatively
Incidence of postoperative side effects such as postoperative nausea and vomiting (PONV), headache, visual disturbances, agitation or somnolence will be recorded.
24 hours postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2025

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

1. juni 2026

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MD-113-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD-delingstidsramme

After the end of study for one year.

IPD-delingsadgangskriterier

The data will be available upon a reasonable request from the corresponding author

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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Kliniske forsøg med Sphenopalatine ganglion block using bupivacaine + dexamethasone

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