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Completed

NCT Number: NCT05301634

Comparison Between Bilateral Infraorbital Block Versus Intranasal Bupivacaine in Transsphenoidal Pituitary Adenoma Resection

The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.

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Key information

Conditions

Intraoperative Hypertension

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Alaini hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I, II or III
  • patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia

Exclusion criteria

  • Patient's refusal
  • Allergy to local anesthetics.
  • Preoperative cerebrospinal fluid leak.
  • Preoperative cardiac arrythmias.
  • Seizure disorders.
  • Patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features.

Treatment and study plan

infraorbital block

Procedure

the patients will receive bilateral infraorbital block

topical intranasal bupivacaine

Procedure

the patients will receive topical intranasal application of bupivacaine

Primary outcomes

  1. Mean arterial blood pressure

    Time frame: at the time of mucosal dissection

Secondary outcomes

  1. Intraoperative need for magnesium sulphate

    Time frame: the entire duration of surgery

    Intraoperative need for iv magnesium sulphate up to 3 mg to maintain blood pressure 20% below baseline

  2. Intraoperative need for fentanyl

    Time frame: the entire duration of surgery

    Intraoperative need for iv fentanyl blouses 0.5 μg/kg (maximum total dose 5 μg/kg for the entire procedure) if no response to magnesium sulphate

  3. Intraoperative need for nitroglycerine

    Time frame: the entire duration of surgery

    Intraoperative need for iv nitroglycerine infusion (5 - 100 mic/min iv) if no response to magnesium sulphate and fentanyl

  4. Postoperative need of pethidine

    Time frame: 24 hours postoprative

    Postoperative need of pethidine boluses 25 mg with max.100 mg

  5. Postoperative pain assessed by Numeric pain score

    Time frame: 24 hours postoprative

    Pain score will be assessed postoperatively (using the verbal Numeric Rating Scale [NRS] 0-100; 0 = Non ,100 = Worst imaginable pain)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison Between Hemodynamic Effect of Bilateral Infraorbital Block Versus Intranasal Application of Bupivacaine in Patients Undergoing Transsphenoidal Pituitary Adenoma Resection.A Comparative Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2022
Registry last updated
Dec 30, 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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