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

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.

Study Overview

• Status: Recruiting
• Conditions: General Anesthesia; Sphenopalatine Ganglion Block; Quality of Surgical Field; Trans-Sphenoidal Endoscopic Hypophysectomy
• Intervention / Treatment: Drug: Sphenopalatine ganglion block using bupivacaine + dexamethasone; Other: General anesthesia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nada A Fathy, MSc; Phone Number: 00201094049394; Email: nashrsf@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Recruiting
    • Cairo University
    • Contact: Nada A Fathy, MSc; Phone Number: 00201094049394; Email: nashrsf@gmail.com
    • Sub-Investigator: Khaled Alshafei, MD
    • Sub-Investigator: Safinaz H Osman, MD
    • Sub-Investigator: Mohamed Farid, MD
    • Sub-Investigator: Maged Gamal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone .	Drug: 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.
Active Comparator: Group B; Patients will receive general anesthesia alone.	Other: General anesthesia; Patients will receive general anesthesia alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of surgical field visibility	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	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	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	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	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	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	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	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	Total postoperative meperidine consumption will be recorded.	24 hours postoperatively
Incidence of postoperative side effects	Incidence of postoperative side effects such as postoperative nausea and vomiting (PONV), headache, visual disturbances, agitation or somnolence will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Anesthesia and Analgesia; Pregnadienetriols; Anesthesia; Dexamethasone; Anesthesia, General
• Other Study ID Numbers: MD-113-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No