Prilocaine for Sphenopalatine Ganglion Block in Endoscopic Hypophysectomy

Kasr El Aini Hospital

Status: Enrolling

Conditions: Blood Pressure Control

Treatments: Procedure: Sphenopalatine Ganglion Block using 2% lidocaine; Procedure: Sphenopalatine Ganglion Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07188987

MS- 403-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups

Group Lidocaine (L)

Active Comparator group

Description:

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

Treatment:

Procedure: Sphenopalatine Ganglion Block using 2% lidocaine

Group Prilocaine (P)

Experimental group

Description:

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

Treatment:

Procedure: Sphenopalatine Ganglion Block

Procedure: Sphenopalatine Ganglion Block

Group Prilocaine adrenaline (PA)

Experimental group

Description:

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

Treatment:

Procedure: Sphenopalatine Ganglion Block

Procedure: Sphenopalatine Ganglion Block