Sphenopalatine Ganglion Block in Endoscopic Transphenoidal Pituitary Gland Surgery

April 14, 2026 updated by: Donia Hany Saad

ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK IN ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY: RANDOMIZED CONTROLLED TRIAL

The primary aim of this study is to compare the effect of bilateral US guided percutaneous PPFB versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia (GA).Secondary aims: total dose of intraoperative dexmedetomidine, intraoperative analgesia (fentanyl), haemodynamics, the surgical field conditions, recovery pattern, and side effects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endoscopic endonasal transsphenoidal resection of pituitary gland is the currently most used method for the resection of pituitary tumors. It is a minimally invasive surgical technique to access sellar and parasellar lesions.

The main goal in endoscopic pituitary surgery are minimal tissue manipulation and clear bloodless field with better panoramic visualization under haemodynamic stability and good postoperative analgesia to improve the outcome .pterygopalatine fossa block (PPFB) is used to maintain haemodynamic stability and to decrease intraoperative anaesthetic requirements (PPFB)can be done transnasal or percutaneous ultrasound guided

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Kafr ash Shaykh, Egypt
        • Kafrelsheikh University
      • Kafr ash Shaykh, Egypt, 23023
        • Kafrelsheikh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients belonging to American Society of Anesthesiologists (ASA) class I or II
  • patients scheduled for Endoscopic Transphenoidal Pituitary gland Surgery

Exclusion Criteria:

Patients will be excluded if; .History of allergy or contraindication to any of the studied drugs.

  • Patients for whom pterygopalatine fossa block is contraindicated (patient refusal, fascial anomalies, coagulation disorder, skin infection at the injection site) .Obese patients with BMI more than 35 Kg/m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bilateral trans-nasal pterygopalatine Fossa block
using 4ml 0.25% bupivacaine after the induction of GA.
Other: trans-nasal pterygopalatine Fossa block
Patients will be placed in 15-degree reverse Trendelenburg position, between the middle and inferior turbinates. This passage will be sterilized by an cotton-tipped applicator soaked with iodine solution. A 20-gauge/5-inch spinal needle will be used after bending 2-3 mm of its tip along the port side with a sterile needle holder to form a 45 angle. The needle will be lubricated with 5% lidocaine jelly, inserted into the nasal meatus and advanced with the bevel pointer facing laterally. Under endoscopic control (0_ optics, 4 mm diameter), the needle will be inserted between middle and inferior turbinate. A total of 4 ml 0.25% bupivacaine will be injected after negative aspiration just behind and over middle turbinate tail, where the pterygopalatine fossa is deeply located.
Active Comparator: Bilateral US-guided infrazygomatic percutaneous pterygopalatine Fossa block
using 4ml 0.25% bupivacaine after the induction of GA
Other: US-guided infrazygomatic percutaneous pterygopalatine Fossa block

US- guided percutaneous PPFB:

Patients will be placed in the lateral head position; the patient's mouth is slightly opened. Following standard sterile preparations, US linear probe covered with sterile sheath is positioned horizontally on the side of the face just below the zygomatic bone superior to the mandibular notch and anterior to the mandibular condyle to visualize the coronoid process, the lateral pterygoid muscle, the lateral pterygoid plate, and the maxillary bone, and the maxillary artery. Needle will be inserted in-plane parallel to the transducer probe and advanced from medial to lateral toward the pterygopalatine fossa. Following negative aspiration, the injectate is deposited deep to the lateral pterygoid muscle and plate. A total of 4 ml 0.25% bupivacaine will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary adenoma in conjucation with general anaesthesia (GA).
Time Frame: recorded after 15 minutes from the induction of anaesthesia, then every 15 minutes till the end of the surgery. Total volume of anaesthetic agent will be measured at the end of the surgery (millimeter /minutes).
The primary aim of this study is to compare the effect of bilateral US guided percutaneous PPFB versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia (GA).
recorded after 15 minutes from the induction of anaesthesia, then every 15 minutes till the end of the surgery. Total volume of anaesthetic agent will be measured at the end of the surgery (millimeter /minutes).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Donia Hany Saad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 15, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sphenopalatine ganglion block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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