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NCT Number: NCT07188987

Prilocaine for Sphenopalatine Ganglion Block in Endoscopic Hypophysectomy

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.

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Key information

Conditions

Blood Pressure Control

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sphenopalatine Ganglion Block using 2% lidocaine

Procedure

Sphenopalatine ganlion block with 2ml of 2% lidocaine and 0.5ml of diluted adrenaline after general anesthesia in patients undergoing enoscopic hypophysectomy.

Sphenopalatine Ganglion Block

Procedure

Sphenopalatine ganlion block with will receive 2ml of 4% prilocaine and 0.5ml saline after general anesthesia in patients undergoing enoscopic hypophysectomy.

Primary outcomes

  1. MAP

    Time frame: Mean arterial blood pressure in mmhg in the intraoperative period 5 minutes after nasal dissection

    mean arterial blood pressure in the intraoperative period 5 minutes after nasal dissection

  2. MAP

    Time frame: Mean arterial blood pressure in mmhg after 5 minutes of nasal dissection

    mean arterial blood presssure 5 minutes after nasal dissection

Secondary outcomes

  1. Mean arterial blood pressure

    Time frame: 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.

  2. Systolic blood pressure

    Time frame: 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.

  3. Diastolic blood preesure

    Time frame: 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.

  4. HR

    Time frame: 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.

  5. Patients needing propranolol

    Time frame: The number of patients throughout the study in the intraoperative period who received propranolol

    The number of patients needing propranolol in each group.

  6. Propranolol needed

    Time frame: The amount of propranolol in mg used throughout the surgery in each group

    The total amount of propranolol in mg used in each group

  7. Patients needing phentolamine

    Time frame: The number of patients receiving phentolamine throughout the surgery in both groups

    The number of patients needing phentolamine in each group.

  8. Phentolamine needed

    Time frame: Throughout the surgical time from the begining to the end of surgery

    The total amount of phentolamine in mg used in each group.

  9. Surgeon satisfaction scale

    Time frame: 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

  10. Time to 1st analgesic requirement

    Time frame: 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

  11. Blood loss

    Time frame: Throughout the surgical time from the begining to the end of surgery

    The total ammount of blood loss in cc

  12. Requirement for transfusion

    Time frame: Throughout the surgical time from the begining to the end of surgery

    The number of patients requiring transfusion

  13. Fentanyl needed

    Time frame: Throughout the surgical time from the begining to the end of surgery

    number of patients needing fentanyl boluses intraoperatively

  14. Total amount of fentanyl

    Time frame: Throughout the surgical time from the begining to the end of surgery

    total ammount of fentanyl needed in micrograms

Study contacts

Contact information is provided by the study sponsor or research team.

Rania Fahmy, Associate Professor

CONTACT

[email protected]

+201270820372

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Bilateral Sphenopalatine Ganglion Block Using Prilocaine Versus Lidocaine as Adjuvants to General Anesthesia During Endoscopic Hypophysectomy, Randomized Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2025
Registry last updated
Dec 5, 2025

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.

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