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Clinical Trials/NCT07569952
NCT07569952RecruitingNot Applicable

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

Cairo University1 site in 1 country70 target enrollmentStarted: June 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
70
Locations
1

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
21 Months to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Group A

Experimental

Patients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone .

Intervention: Sphenopalatine ganglion block using bupivacaine + dexamethasone (Drug)

Group B

Active Comparator

Patients will receive general anesthesia alone.

Intervention: General anesthesia (Other)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nada Ashraf Mohamed Fathy

Assistant Lecturer of Anesthesiology, Surgical ICU and Pain Management, Cairo University, Cairo, Egypt.

Cairo University

Study Sites (1)

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