Prilocaine for Sphenopalatine Ganglion Block in Endoscopic Hypophysectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Blood Pressure Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group Lidocaine (L)

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

Group Type ACTIVE_COMPARATOR

Sphenopalatine Ganglion Block using 2% lidocaine

Intervention Type PROCEDURE

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

Group Prilocaine (P)

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

Group Type EXPERIMENTAL

Sphenopalatine Ganglion Block

Intervention Type 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 adrenaline (PA)

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

Group Type EXPERIMENTAL

Sphenopalatine Ganglion Block

Intervention Type PROCEDURE

Sphenopalatine ganlion block with will receive 2ml of 4% prilocaine in addition to 0.5ml of diluted adrenaline. after general anesthesia in patients undergoing enoscopic hypophysectomy.

Interventions

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Sphenopalatine Ganglion Block using 2% lidocaine

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

Intervention Type PROCEDURE

Sphenopalatine Ganglion Block

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

Intervention Type PROCEDURE

Sphenopalatine Ganglion Block

Sphenopalatine ganlion block with will receive 2ml of 4% prilocaine in addition to 0.5ml of diluted adrenaline. after general anesthesia in patients undergoing enoscopic hypophysectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No