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Recruiting NCT07569952

Sphenopalatine Ganglion Block as Adjuvant to General Anesthesia Regarding the Quality of Surgical Field in Trans-Sphenoidal Endoscopic Hypophysectomy

No phase Interventional Sphenopalatine Ganglion Block General Anesthesia Quality of Surgical Field Trans-Sphenoidal Endoscopic Hypophysectomy

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 bupivacaine + dexamethasone, General anesthesia.
Who it may be relevant to
Registry conditions: Sphenopalatine Ganglion Block, General Anesthesia, Quality of Surgical Field, Trans-Sphenoidal Endoscopic Hypophysectomy. Basic parameters: 21 months — 60 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 →
Official title

The Efficacy of Ultrasound Guided Sphenopalatine Ganglion Block as Adjuvant to General Anesthesia Regarding the Quality of Surgical Field in Trans-Sphenoidal Endoscopic Hypophysectomy: A Randomized Controlled Trial

Overview

This study aims to evaluate the efficacy of ultrasound guided sphenopalatine ganglion block (SPGB) through the suprazygomatic approach in optimizing the quality of surgical field as well as its effect on postoperative pain relief in patients undergoing transsphenoidal pituitary surgeries under general anesthesia.

Detailed description

The main surgical treatment for pituitary adenomas is endoscopic trans-sphenoidal hypophysectomy.

Among the many regional blocks used is the sphenopalatine ganglion block (SPGB). It is one of the parasympathetic ganglia in the head, located in the pterygopalatine fossa, posterior to the middle nasal turbinate, 1-5 mm deep to the mucosa, anterior to the pterygoid canal and lateral to the sphenopalatine foramen.

This superficial location makes it easy to block the ganglion transnasally by topical anesthesia or by injection through many approaches including transnasal, intraoral, infrazygomatic and suprazygomatic approaches.

Interventions

  • Drug Sphenopalatine ganglion block using bupivacaine + dexamethasone
    Patients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone.
  • Other General anesthesia
    Patients will receive general anesthesia alone.

Primary outcome measures

  • Quality of surgical field visibility [Time frame: Intraoperatively]
Secondary outcome measures (8)
  • Intraoperative fentanyl consumption [Time frame: Intraoperatively]
  • Total dose of propranolol [Time frame: Intraoperatively]
  • Total dose of nitroglycerine [Time frame: Intraoperatively]
  • Amount of intraoperative blood loss [Time frame: Intraoperatively]
  • Degree of pain [Time frame: 24 hours postoperatively]
  • Time of 1st analgesia requirement [Time frame: 24 hours postoperatively]
  • Total meperidine consumption [Time frame: 24 hours postoperatively]
  • Incidence of postoperative side effects [Time frame: 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • Age between 21 and 60 years.
  • American Society of Anesthesiologists (ASA) Physical Status I or II.
  • Undergoing elective endoscopic trans-nasal resection of pituitary adenoma.

Exclusion criteria

  • Patient's refusal
  • ASA Physical Status III or IV patients
  • Patients receiving drugs influencing blood coagulation
  • Allergy to any of the drugs utilized in this study
  • History of chronic pain therapy
  • Inadvertent intra-operative vascular injury

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
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT07569952 · MD-113-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗