Prilocaine for Sphenopalatine Ganglion Block in Endoscopic Hypophysectomy

Not Applicable

Not yet recruiting

• Conditions: Blood Pressure Control

• Registration Number: NCT07188987
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

Patients undergoing endoscopic surgeries for pituitary adenoma excision suffer from wide swings in blood pressure that might increase bleeding and interfere with the surgical field.

Local anethetic infiltration and regional nerve blocks have been used to provide better analgesia, control blood pressure and improve surgical field.

Limited studies evaluated shenopalatine ganglion block in pituitary adenoma excision with promising outcomes. The proposed study will compare the efficacy of two local anesthetics, prilocaine and lidocaine, for spenopalatine ganglion block in patients undergoing endoscopic pituitary adenoma excision. Evaluating the control of the intraoperative blood pressure and analgesic sparing are the main objectives of the proposed study.

Detailed Description

Pituitary adenoma excision through endoscopic sinus surgery has been evolving over the years. Though less traumatic less traumatic and less invasive than other approaches, hemodynamic variations during several phases of the surgey as nasal dissection pose challenges for anesthesiologists.

Regional techniques present appealing options for better control of blood pressure during periods of maximal surgical stimulation, they may as well provide a better surgical field. One of the regional techniques is the sphenopalatine ganglion bock where a local anesthetic is injected in the pterygopalatine fossa around the sphenopalatine ganglion. Thus, It blocks pain transmission through the branches of the trigeminal nerve.

The current study was designed to compare the effects of two local anesthetics, lidocaine versus prilocaine on intraoperative hemodynamics, surgical field and analgesia.

Study Timeline

• Study First Submitted: 2025-08-28
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients with pituitary adenoma undergoing endoscopic hypophysectomy.
• ASA physical status I and II.
• Age above 21, below 45 years.
• Male or female

Exclusion Criteria

• Any patient below 21 years or above 45 years.

• Patients suffering from any of the following conditions:

  • Disturbed conscious level.
  • Coagulation abnormalities.
  • Poorly controlled blood pressure and/or heart rate.
  • Increased intracranial tension.
  • Liver and kidney disorders.

• Patients on anticoagulants and/or NSAIDS (non-steroidal anti- inflammatory drugs

• Patients addicted to drugs and/or alcohol.

• Patients with disturbed conscious level at the end of the surgery, GCS >14

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MAP	Mean arterial blood pressure in mmhg after 5 minutes of nasal dissection	mean arterial blood presssure 5 minutes after nasal dissection

Secondary Outcome Measures

Name	Time	Method
Mean arterial blood pressure	Before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.	Mean arterial blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Systolic blood pressure	Systolic blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.	Systolic blood pressure before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Diastolic blood preesure	Diastolic blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.	Diastolic blood pressure before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
HR	Heart rate in beats/min before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.	Heart rate before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Patients needing propranolol	The number of patients throughout the study in the intraoperative period who received propranolol	The number of patients needing propranolol in each group.
Propranolol needed	The amount of propranolol in mg used throughout the surgery in each group	The total amount of propranolol in mg used in each group
Patients needing phentolamine	The number of patients receiving phentolamine throughout the surgery in both groups	The number of patients needing phentolamine in each group.
Phentolamine needed	Throughout the surgical time from the begining to the end of surgery	The total amount of phentolamine in mg used in each group.
Surgeon satisfaction scale	10 minutes after the end of surgery.	Surgeon satisfaction scale based on Average category scale (ACS) from 0 to 5 with 0 meaning no bleeding and 5 massive uncontrollable bleeding
Time to 1st analgesic requirement	The time in hours from emergence of anaesthesia till the request of first rescue analgesia in the first 24 hours after surgery	The time from emergence of anaesthesia till the request of first rescue analgesia
Blood loss	Throughout the surgical time from the begining to the end of surgery	The total ammount of blood loss in cc
Requirement for transfusion	Throughout the surgical time from the begining to the end of surgery	The number of patients requiring transfusion
Fentanyl needed	Throughout the surgical time from the begining to the end of surgery	number of patients needing fentanyl boluses intraoperatively
Total amount of fentanyl	Throughout the surgical time from the begining to the end of surgery	total ammount of fentanyl needed in micrograms

Trial Locations

Locations (1)

Kasr El Ainy; 🇪🇬 Cairo, Egypt