Sphenopalatine Ganglion Block in Endoscopic Transphenoidal Pituitary Gland Surgery

NCT ID: NCT06836583

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-27
• Study Completion Date: 2025-04-15

Brief Summary

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

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

Conditions

ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK in ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bilateral trans-nasal pterygopalatine Fossa block

using 4ml 0.25% bupivacaine after the induction of GA.

Group Type: ACTIVE_COMPARATOR

trans-nasal pterygopalatine Fossa block

Intervention Type: 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.

Bilateral US-guided infrazygomatic percutaneous pterygopalatine Fossa block

using 4ml 0.25% bupivacaine after the induction of GA

Group Type: ACTIVE_COMPARATOR

US-guided infrazygomatic percutaneous pterygopalatine Fossa block

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Donia Hany Saad

Lecturer of anaesthesia and surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Donia Hany Aboadmaa, MD

Role: CONTACT

doniahany1788@gmail.com

01014498540

Other Identifiers

sphenopalatine ganglion block

Identifier Type: -

Identifier Source: org_study_id