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Recruiting NCT07188987

Prilocaine for Sphenopalatine Ganglion Block in Endoscopic Hypophysectomy

No phase Interventional Blood Pressure Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sphenopalatine Ganglion Block using 2% lidocaine, Sphenopalatine Ganglion Block, Sphenopalatine Ganglion Block.
Who it may be relevant to
Registry conditions: Blood Pressure Control. Basic parameters: 21 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure 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.
  • 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.
  • 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.

Primary outcome measures

  • MAP [Time frame: Mean arterial blood pressure in mmhg in the intraoperative period 5 minutes after nasal dissection]
  • MAP [Time frame: Mean arterial blood pressure in mmhg after 5 minutes of nasal dissection]
Secondary outcome measures (12)
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • Patients needing propranolol [Time frame: The number of patients throughout the study in the intraoperative period who received propranolol]
  • Propranolol needed [Time frame: The amount of propranolol in mg used throughout the surgery in each group]
  • Patients needing phentolamine [Time frame: The number of patients receiving phentolamine throughout the surgery in both groups]
  • Phentolamine needed [Time frame: Throughout the surgical time from the begining to the end of surgery]
  • Surgeon satisfaction scale [Time frame: 10 minutes after the end of surgery.]
  • 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]
  • Blood loss [Time frame: Throughout the surgical time from the begining to the end of surgery]
  • Requirement for transfusion [Time frame: Throughout the surgical time from the begining to the end of surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Kasr El Ainy — Cairo

Publications

  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07188987 · MS- 403-2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗