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NCT Number: NCT07569952

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

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.

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Key information

Conditions

Sphenopalatine Ganglion Block General Anesthesia Quality of Surgical Field Trans-Sphenoidal Endoscopic Hypophysectomy

Age range

21 month–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Khaled Alshafei, MD

SUB_INVESTIGATOR

Maged Gamal, MD

SUB_INVESTIGATOR

Mohamed Farid, MD

SUB_INVESTIGATOR

Nada A Fathy, MSc

CONTACT

[email protected]

00201094049394

Safinaz H Osman, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sphenopalatine ganglion block using bupivacaine + dexamethasone

Drug

Patients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone.

General anesthesia

Other

Patients will receive general anesthesia alone.

Primary outcomes

  1. Quality of surgical field visibility

    Time frame: 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

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

Secondary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: 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

  2. Total dose of propranolol

    Time frame: 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.

  3. Total dose of nitroglycerine

    Time frame: 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.

  4. Amount of intraoperative blood loss

    Time frame: 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)

  5. Degree of pain

    Time frame: 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.

  6. Time of 1st analgesia requirement

    Time frame: 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.

  7. Total meperidine consumption

    Time frame: 24 hours postoperatively

    Total postoperative meperidine consumption will be recorded.

  8. Incidence of postoperative side effects

    Time frame: 24 hours postoperatively

    Incidence of postoperative side effects such as postoperative nausea and vomiting (PONV), headache, visual disturbances, agitation or somnolence will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Nada A Fathy, MSc

CONTACT

[email protected]

00201094049394

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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