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Completed

NCT Number: NCT06836583

Sphenopalatine Ganglion Block in Endoscopic Transphenoidal Pituitary Gland Surgery

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University, Kafr ash Shaykh, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

trans-nasal pterygopalatine Fossa block

Other

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.

US-guided infrazygomatic percutaneous pterygopalatine Fossa block

Other

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.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Donia Hany Saad

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Apr 17, 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.