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

NCT07569952 | Recruiting

• 1 other identifier: MD-113-2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sphenopalatine Ganglion Block; General Anesthesia; Quality of Surgical Field; Trans-Sphenoidal Endoscopic Hypophysectomy

Outcome Measures

Primary Outcomes (1)

• Quality of surgical field visibility

  Quality of surgical field visibility will be measured at the beginning of surgery and at 30 mins interval through a pre-defined average category scale (ACS) (from 0 to 5). The ideal category scale values for surgical conditions were pre-determined to be ≤3. 0=No bleeding 1. Slight bleeding - no suctioning of blood required 2. Slight bleeding - occasional suctioning required. Surgical field not threatened 3. Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed 4. Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed 5. Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible

  Intraoperatively

Secondary Outcomes (8)

• Intraoperative fentanyl consumption

  Intraoperatively

• Total dose of propranolol

  Intraoperatively

• Total dose of nitroglycerine

  Intraoperatively

• Amount of intraoperative blood loss

  Intraoperatively

• Degree of pain

  24 hours postoperatively

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: Sphenopalatine ganglion block using bupivacaine + dexamethasone

Group B

ACTIVE COMPARATOR

Patients will receive general anesthesia alone.

Other: General anesthesia

Interventions

Sphenopalatine ganglion block using bupivacaine + dexamethasone DRUG

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

Group A

General anesthesia OTHER

Patients will receive general anesthesia alone.

Group B

Eligibility Criteria

• Age: 21 Months - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Dexamethasone; Anesthesia, General

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Nada A Fathy, MSc

CONTACT

00201094049394; nashrsf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical ICU and Pain Management, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 6, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)