Sphenopalatine Ganglion BlockNCT07569952
Sphenopalatine Ganglion Block as Adjuvant to General Anesthesia Regarding the Quality of Surgical Field in Trans-Sphenoidal Endoscopic Hypophysectomy
A study testing Sphenopalatine ganglion block using bupivacaine + dexamethasone and General anesthesia in people with Sphenopalatine Ganglion Block and General Anesthesia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 months to 60 years
- Conditions the study is for
- Sphenopalatine Ganglion Block, General Anesthesia, Quality of Surgical Field
- What is being tested?
- Sphenopalatine ganglion block using bupivacaine + dexamethasone and General anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 months to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Nada A Fathy, MSc, 00201094049394, nashrsf@gmail.com
Khaled Alshafei, MD
About this study
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
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.
Read the 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.
- Conditions
- Sphenopalatine Ganglion Block, General Anesthesia, Quality of Surgical Field, Trans-Sphenoidal Endoscopic Hypophysectomy
- Being tested
- Sphenopalatine ganglion block using bupivacaine + dexamethasone, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine ganglion block using bupivacaine + dexamethasoneDrug
Patients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone.
General anesthesiaOther
Patients will receive general anesthesia alone.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone . Receives: Drug: Sphenopalatine ganglion block using bupivacaine + dexamethasone |
| Group B | Active comparator | Patients will receive general anesthesia alone. Receives: Other: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Slight bleeding - no suctioning of blood required
- Slight bleeding - occasional suctioning required. Surgical field not threatened
- Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed
- Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed
- Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible
Measured: Intraoperatively
Secondary outcomes (8)
Intraoperative fentanyl consumption
The hemodynamic objective of the anesthetic plan is to maintain mean arterial pressure values between 60 mmHg and 65 mmHg to produce an optimal surgical field, this will be done by injection of increments of fentanyl (0.5 μg/kg) up to total dose of 3 μg/kg
Measured: Intraoperatively
Total dose of propranolol
In case of reflex persistent increase in heart rate (HR) >100 beats/min, i.v. 0.2 mg increments of propranolol will be given to maintain HR 60-70 beats/min.
Measured: Intraoperatively
Total dose of nitroglycerine
In case of reduction of mean arterial pressure (MAP), nitroglycerine infusion will be done through adjustment from 0.5 to 10 μg/kg/ min according to patient response.
Measured: Intraoperatively
Amount of intraoperative blood loss
Amount of intraoperative blood loss (by measuring the volume of blood in suction reservoir minus the normal saline used to wash the surgical field)
Measured: Intraoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be measured immediately after the operation, then at 2, 12, and 24hrs.
Measured: 24 hours postoperatively
Time of 1st analgesia requirement
Postoperative analgesia is performed with administration of paracetamol/acetaminophen (1 g three times a day) and visual analog scale (VAS) ≥4 will be managed by IV dose of 25mg pethidine.
Measured: 24 hours postoperatively
Total meperidine consumption
Total postoperative meperidine consumption will be recorded.
Measured: 24 hours postoperatively
Incidence of postoperative side effects
Incidence of postoperative side effects such as postoperative nausea and vomiting (PONV), headache, visual disturbances, agitation or somnolence will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sphenopalatine Ganglion BlockStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Ashraf Mohamed Fathy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569952
- Sponsor's protocol ID
- MD-113-2025
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07569952
- Acronym / sponsor ID
- MD-113-2025
- Conditions
- Sphenopalatine Ganglion Block, General Anesthesia, Quality of Surgical Field, Trans-Sphenoidal Endoscopic Hypophysectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Sphenopalatine ganglion block using bupivacaine + dexamethasonePatients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone . |
| Group B | Active comparator | Other: General anesthesiaPatients will receive general anesthesia alone. |
Who may qualify
- Ages
- 21 months to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sphenopalatine ganglion block using bupivacaine + dexamethasonePatients will receive sphenopalatine ganglion block (SPGB) using 4 mL of 0.25% bupivacaine combined with 1 mL of dexamethasone. | Drug | Group A |
| General anesthesiaPatients will receive general anesthesia alone. | Other | Group B |
Primary outcome
Quality of surgical field visibility
Time frame: Intraoperatively
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Sphenopalatine Ganglion Block
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Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Not yet recruiting
Sphenopalatine Ganglion Block Combined With Either Scalp Nerve Block or Local Wound Infiltration for Postoperative Analgesia in Adult Patients Undergoing Craniotomy: A Randomized Controlled Trial
Craniotomy Surgery
Not yet recruitingPhase 4
Sphenopalatine Ganglion Block for Pain Relief After Pediatric Adenotonsillectomy
Postoperative Pain, Tonsillectomy
RecruitingPhase 2/3
Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache
SAH (Subarachnoid Hemorrhage), Headache
RecruitingPhase 4
Intranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sphenopalatine ganglion block using bupivacaine + dexamethasone and General anesthesia in people with Sphenopalatine Ganglion Block and General Anesthesia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nada A Fathy, MSc (00201094049394, nashrsf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of surgical field visibility (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.