Prilocaine for Sphenopalatine Ganglion Block in Endoscopic Hypophysectomy

NCT07188987 | Recruiting

• 1 other identifier: MS- 403-2021
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure Control

Keywords

Sphenopalatine ganglion block; Prilocaine; lidocaine; endoscopic hypophysectomy

Outcome Measures

Primary Outcomes (2)

• MAP

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

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

• MAP

  mean arterial blood presssure 5 minutes after nasal dissection

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

Secondary Outcomes (14)

• 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.

• 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.

• 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.

• 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.

• Patients needing propranolol

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

Study Arms (3)

Group Lidocaine (L)

ACTIVE COMPARATOR

Group L will receive 2ml of 2% lidocaine and 0.5ml of diluted adrenaline.

Procedure: Sphenopalatine Ganglion Block using 2% lidocaine

Group Prilocaine (P)

EXPERIMENTAL

Group P will receive 2ml of 4% prilocaine and 0.5ml saline

Procedure: Sphenopalatine Ganglion Block

Group Prilocaine adrenaline (PA)

EXPERIMENTAL

Group PA will receive 2ml of 4% prilocaine and 0.5ml of diluted adrenaline.

Procedure: Sphenopalatine Ganglion Block

Interventions

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.

Group Lidocaine (L)

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.

Group Prilocaine (P)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Ainy

Cairo, 11956, Egypt

RECRUITING

Related Publications (4)

• Chaudhary R, Payal YS, Mohapatra B, Sony S, Shekhar S. USG-guided bilateral sphenopalatine ganglion block: A useful anesthetic adjuvant for trans nasal trans sphenoidal pituitary surgery in a patient with severely low ejection fraction. Saudi J Anaesth. 2025 Jan-Mar;19(1):102-104. doi: 10.4103/sja.sja_388_24. Epub 2025 Jan 1.

  PMID: 39958315 BACKGROUND

• Rezaeian A, Hashemi SM, Dokhanchi ZS. Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Sinus Surgery. Allergy Rhinol (Providence). 2019 Jan 23;10:2152656718821282. doi: 10.1177/2152656718821282. eCollection 2019 Jan-Dec.

  PMID: 30719401 BACKGROUND

• Cafiero T, Cavallo LM, Frangiosa A, Burrelli R, Gargiulo G, Cappabianca P, de Divitiis E. Clinical comparison of remifentanil-sevoflurane vs. remifentanil-propofol for endoscopic endonasal transphenoidal surgery. Eur J Anaesthesiol. 2007 May;24(5):441-6. doi: 10.1017/S0265021506002080. Epub 2007 Mar 12.

  PMID: 17376252 BACKGROUND

• Jane JA Jr, Thapar K, Kaptain GJ, Maartens N, Laws ER Jr. Pituitary surgery: transsphenoidal approach. Neurosurgery. 2002 Aug;51(2):435-42; discussion 442-4.

  PMID: 12182782 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Sphenopalatine Ganglion Block

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Rania Fahmy, Associate Professor

CONTACT

+201270820372; ransam98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 23, 2025
• Study Start: December 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD can be available 3 months after completion of the study
• Access Criteria: IPD can be accessed from the authors by journals considering the study for publication and upon reasonable request from other investigators

Locations

EG (1)