ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK IN ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERYNCT06836583
Sphenopalatine Ganglion Block in Endoscopic Transphenoidal Pituitary Gland Surgery
A study testing trans-nasal pterygopalatine Fossa block and US-guided infrazygomatic percutaneous pterygopalatine Fossa block in people with ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK IN ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY, run by Donia Hany Saad at 2 sites in Egypt.
Trial summary
The primary aim of this study is to compare the effect of bilateral US guided percutaneous PPFB versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK IN ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY
- What is being tested?
- trans-nasal pterygopalatine Fossa block and US-guided infrazygomatic percutaneous pterygopalatine Fossa block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 27 Feb 2025to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients belonging to American Society of Anesthesiologists (ASA) class I or II
- patients scheduled for Endoscopic Transphenoidal Pituitary gland Surgery
Who cannot join
- Patients will be excluded if; .History of allergy or contraindication to any of the studied drugs.
- Patients for whom pterygopalatine fossa block is contraindicated (patient refusal, fascial anomalies, coagulation disorder, skin infection at the injection site) .Obese patients with BMI more than 35 Kg/m2.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Kafrelsheikh University
Kafr ash Shaykh, 23023
Kafrelsheikh University
Kafr ash Shaykh
About this study
Official title: ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK IN ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY: RANDOMIZED CONTROLLED TRIAL
The primary aim of this study is to compare the effect of bilateral US guided percutaneous PPFB versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia (GA).Secondary aims: total dose of intraoperative dexmedetomidine, intraoperative analgesia (fentanyl), haemodynamics, the surgical field conditions, recovery pattern, and side effects
Read the detailed description
Endoscopic endonasal transsphenoidal resection of pituitary gland is the currently most used method for the resection of pituitary tumors. It is a minimally invasive surgical technique to access sellar and parasellar lesions.
The main goal in endoscopic pituitary surgery are minimal tissue manipulation and clear bloodless field with better panoramic visualization under haemodynamic stability and good postoperative analgesia to improve the outcome .pterygopalatine fossa block (PPFB) is used to maintain haemodynamic stability and to decrease intraoperative anaesthetic requirements (PPFB)can be done transnasal or percutaneous ultrasound guided
- Being tested
- trans-nasal pterygopalatine Fossa block, US-guided infrazygomatic percutaneous pterygopalatine Fossa block
- Keywords
- sphenopalatine ganglion block, transphenoidal pituitary gland surgery, ultrasound guided sphenopalatine ganglion block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-nasal pterygopalatine Fossa blockOther
Patients will be placed in 15-degree reverse Trendelenburg position, between the middle and inferior turbinates. This passage will be sterilized by an cotton-tipped applicator soaked with iodine solution. A 20-gauge/5-inch spinal needle will be used after bending 2-3 mm of its tip along the port side with a sterile needle holder to form a 45 angle. The needle will be lubricated with 5% lidocaine jelly, inserted into the nasal meatus and advanced with the bevel pointer facing laterally. Under endoscopic control (0_ optics, 4 mm diameter), the needle will be inserted between middle and inferior turbinate. A total of 4 ml 0.25% bupivacaine will be injected after negative aspiration just behind and over middle turbinate tail, where the pterygopalatine fossa is deeply located.
US-guided infrazygomatic percutaneous pterygopalatine Fossa blockOther
US- guided percutaneous PPFB:
Patients will be placed in the lateral head position; the patient's mouth is slightly opened. Following standard sterile preparations, US linear probe covered with sterile sheath is positioned horizontally on the side of the face just below the zygomatic bone superior to the mandibular notch and anterior to the mandibular condyle to visualize the coronoid process, the lateral pterygoid muscle, the lateral pterygoid plate, and the maxillary bone, and the maxillary artery. Needle will be inserted in-plane parallel to the transducer probe and advanced from medial to lateral toward the pterygopalatine fossa. Following negative aspiration, the injectate is deposited deep to the lateral pterygoid muscle and plate. A total of 4 ml 0.25% bupivacaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral trans-nasal pterygopalatine Fossa block | Active comparator | using 4ml 0.25% bupivacaine after the induction of GA. Receives: Other: trans-nasal pterygopalatine Fossa block |
| Bilateral US-guided infrazygomatic percutaneous pterygopalatine Fossa block | Active comparator | using 4ml 0.25% bupivacaine after the induction of GA Receives: Other: US-guided infrazygomatic percutaneous pterygopalatine Fossa block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary adenoma in conjucation with general anaesthesia (GA).
The primary aim of this study is to compare the effect of bilateral US guided percutaneous PPFB versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia (GA).
Measured: recorded after 15 minutes from the induction of anaesthesia, then every 15 minutes till the end of the surgery. Total volume of anaesthetic agent will be measured at the end of the surgery (millimeter /minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start27 Feb 2025
- Primary completion1 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK IN ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERYStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donia Hany Saad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Donia Hany Saad, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836583
- Sponsor's protocol ID
- sphenopalatine ganglion block
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saad DH, Ahmed AMM, ElKholy WM, Bakr MM. Ultrasound-guided percutaneous versus trans-nasal pterygopalatine fossa block in endoscopic trans-sphenoidal pituitary gland surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Feb 2;26(1):139. doi: 10.1186/s12871-026-03618-0.
PubMed 41622136
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK IN ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY: RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT06836583
- Acronym / sponsor ID
- sphenopalatine ganglion block
- Keywords
- sphenopalatine ganglion block, transphenoidal pituitary gland surgery, ultrasound guided sphenopalatine ganglion block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Donia Hany SaadUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 20 Feb 2025 (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.
The primary aim of this study is to compare the effect of bilateral US guided percutaneous PPFB versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia (GA).Secondary aims: total dose of intraoperative dexmedetomidine, intraoperative analgesia (fentanyl), haemodynamics, the surgical field conditions, recovery pattern, and side effects
Detailed description
Endoscopic endonasal transsphenoidal resection of pituitary gland is the currently most used method for the resection of pituitary tumors. It is a minimally invasive surgical technique to access sellar and parasellar lesions.
The main goal in endoscopic pituitary surgery are minimal tissue manipulation and clear bloodless field with better panoramic visualization under haemodynamic stability and good postoperative analgesia to improve the outcome .pterygopalatine fossa block (PPFB) is used to maintain haemodynamic stability and to decrease intraoperative anaesthetic requirements (PPFB)can be done transnasal or percutaneous ultrasound guided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral trans-nasal pterygopalatine Fossa block | Active comparator | Other: trans-nasal pterygopalatine Fossa blockusing 4ml 0.25% bupivacaine after the induction of GA. |
| Bilateral US-guided infrazygomatic percutaneous pterygopalatine Fossa block | Active comparator | Other: US-guided infrazygomatic percutaneous pterygopalatine Fossa blockusing 4ml 0.25% bupivacaine after the induction of GA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients belonging to American Society of Anesthesiologists (ASA) class I or II
- patients scheduled for Endoscopic Transphenoidal Pituitary gland Surgery
Key exclusion criteria (2 listed)
- Patients will be excluded if; .History of allergy or contraindication to any of the studied drugs.
- Patients for whom pterygopalatine fossa block is contraindicated (patient refusal, fascial anomalies, coagulation disorder, skin infection at the injection site) .Obese patients with BMI more than 35 Kg/m2.
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 |
|---|---|---|
| trans-nasal pterygopalatine Fossa blockPatients will be placed in 15-degree reverse Trendelenburg position, between the middle and inferior turbinates. This passage will be sterilized by an cotton-tipped applicator soaked with iodine solution. A 20-gauge/5-inch spinal needle will be used after bending 2-3 mm of its tip along the port side with a sterile needle holder to form a 45 angle. The needle will be lubricated with 5% lidocaine jelly, inserted into the nasal meatus and advanced with the bevel pointer facing laterally. Under endoscopic control (0_ optics, 4 mm diameter), the needle will be inserted between middle and inferior turbinate. A total of 4 ml 0.25% bupivacaine will be injected after negative aspiration just behind and over middle turbinate tail, where the pterygopalatine fossa is deeply located. | Other | Bilateral trans-nasal pterygopalatine Fossa block |
| US-guided infrazygomatic percutaneous pterygopalatine Fossa blockUS- guided percutaneous PPFB: Patients will be placed in the lateral head position; the patient's mouth is slightly opened. Following standard sterile preparations, US linear probe covered with sterile sheath is positioned horizontally on the side of the face just below the zygomatic bone superior to the mandibular notch and anterior to the mandibular condyle to visualize the coronoid process, the lateral pterygoid muscle, the lateral pterygoid plate, and the maxillary bone, and the maxillary artery. Needle will be inserted in-plane parallel to the transducer probe and advanced from medial to lateral toward the pterygopalatine fossa. Following negative aspiration, the injectate is deposited deep to the lateral pterygoid muscle and plate. A total of 4 ml 0.25% bupivacaine will be injected. | Other | Bilateral US-guided infrazygomatic percutaneous pterygopalatine Fossa block |
Primary outcome
Intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary adenoma in conjucation with general anaesthesia (GA).
Time frame: recorded after 15 minutes from the induction of anaesthesia, then every 15 minutes till the end of the surgery. Total volume of anaesthetic agent will be measured at the end of the surgery (millimeter /minutes).
The primary aim of this study is to compare the effect of bilateral US guided percutaneous PPFB versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia (GA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Derived from this study: PubMed 41622136Saad DH, Ahmed AMM, ElKholy WM, Bakr MM. Ultrasound-guided percutaneous versus trans-nasal pterygopalatine fossa block in endoscopic trans-sphenoidal pituitary gland surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Feb 2;26(1):139. doi: 10.1186/s12871-026-03618-0.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans-nasal pterygopalatine Fossa block and US-guided infrazygomatic percutaneous pterygopalatine Fossa block in people with ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK IN ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY, run by Donia Hany Saad at 2 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary adenoma in conjucation with general anaesthesia (GA). (time frame: recorded after 15 minutes from the induction of anaesthesia, then every 15 minutes till the end of the surgery. Total volume of anaesthetic agent will be measured at the end of the surgery (millimeter /minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06836583, which also lists 1 linked publication.
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 17 Apr 2026.