Sphenopalatine Ganglion Block in Endoscopic Transphenoidal Pituitary Gland Surgery

Kafrelsheikh University

Status and phase: Not yet enrolling; Phase 3; Phase 2

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

Treatments: Other: trans-nasal pterygopalatine Fossa block; Other: US-guided infrazygomatic percutaneous pterygopalatine Fossa block

Study type: Interventional

Funder types: Other

Identifiers

NCT06836583

sphenopalatine ganglion block

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Bilateral trans-nasal pterygopalatine Fossa block

Active Comparator group

Description:

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

Treatment:

Other: trans-nasal pterygopalatine Fossa block

Bilateral US-guided infrazygomatic percutaneous pterygopalatine Fossa block

Active Comparator group

Description:

using 4ml 0.25% bupivacaine after the induction of GA

Treatment:

Other: US-guided infrazygomatic percutaneous pterygopalatine Fossa block