Blood Pressure ControlNCT07188987
Prilocaine for Sphenopalatine Ganglion Block in Endoscopic Hypophysectomy
A study testing Sphenopalatine Ganglion Block using 2% lidocaine and Sphenopalatine Ganglion Block in people with Blood Pressure Control, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Patients undergoing endoscopic surgeries for pituitary adenoma excision suffer from wide swings in blood pressure that might increase bleeding and interfere with the surgical field. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Blood Pressure Control
- What is being tested?
- Sphenopalatine Ganglion Block using 2% lidocaine and Sphenopalatine Ganglion Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to Feb 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with pituitary adenoma undergoing endoscopic hypophysectomy.
- ASA physical status I and II.
- Age above 21, below 45 years.
- Male or female
Who cannot join
- Any patient below 21 years or above 45 years.
- Patients suffering from any of the following conditions:
- Disturbed conscious level.
- Coagulation abnormalities.
- Poorly controlled blood pressure and/or heart rate.
- Increased intracranial tension.
Show all 10Show fewer
- Liver and kidney disorders.
- Patients on anticoagulants and/or NSAIDS (non-steroidal anti- inflammatory drugs
- Patients addicted to drugs and/or alcohol.
- Patients with disturbed conscious level at the end of the surgery, GCS >14
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
Kasr El Ainy
Cairo, 11956
Rania Fahmy, Associate Professor, +201270820372, ransam98@gmail.com
About this study
Official title: Bilateral Sphenopalatine Ganglion Block Using Prilocaine Versus Lidocaine as Adjuvants to General Anesthesia During Endoscopic Hypophysectomy, Randomized Trial.
Patients undergoing endoscopic surgeries for pituitary adenoma excision suffer from wide swings in blood pressure that might increase bleeding and interfere with the surgical field.
Local anethetic infiltration and regional nerve blocks have been used to provide better analgesia, control blood pressure and improve surgical field.
Limited studies evaluated shenopalatine ganglion block in pituitary adenoma excision with promising outcomes. The proposed study will compare the efficacy of two local anesthetics, prilocaine and lidocaine, for spenopalatine ganglion block in patients undergoing endoscopic pituitary adenoma excision. Evaluating the control of the intraoperative blood pressure and analgesic sparing are the main objectives of the proposed study.
Read the detailed description
Pituitary adenoma excision through endoscopic sinus surgery has been evolving over the years. Though less traumatic less traumatic and less invasive than other approaches, hemodynamic variations during several phases of the surgey as nasal dissection pose challenges for anesthesiologists.
Regional techniques present appealing options for better control of blood pressure during periods of maximal surgical stimulation, they may as well provide a better surgical field. One of the regional techniques is the sphenopalatine ganglion bock where a local anesthetic is injected in the pterygopalatine fossa around the sphenopalatine ganglion. Thus, It blocks pain transmission through the branches of the trigeminal nerve.
The current study was designed to compare the effects of two local anesthetics, lidocaine versus prilocaine on intraoperative hemodynamics, surgical field and analgesia.
- Conditions
- Blood Pressure Control
- Being tested
- Sphenopalatine Ganglion Block using 2% lidocaine, Sphenopalatine Ganglion Block
- Keywords
- Sphenopalatine ganglion block, Prilocaine, lidocaine, endoscopic hypophysectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion Block using 2% lidocaineProcedure or surgery
Sphenopalatine ganlion block with 2ml of 2% lidocaine and 0.5ml of diluted adrenaline after general anesthesia in patients undergoing enoscopic hypophysectomy.
Sphenopalatine Ganglion BlockProcedure or surgery
Sphenopalatine ganlion block with will receive 2ml of 4% prilocaine and 0.5ml saline after general anesthesia in patients undergoing enoscopic hypophysectomy.
Sphenopalatine Ganglion BlockProcedure or surgery
Sphenopalatine ganlion block with will receive 2ml of 4% prilocaine in addition to 0.5ml of diluted adrenaline. after general anesthesia in patients undergoing enoscopic hypophysectomy.
| Study group | Role | What they receive |
|---|---|---|
| Group Lidocaine (L) | Active comparator | Group L will receive 2ml of 2% lidocaine and 0.5ml of diluted adrenaline. Receives: Procedure: Sphenopalatine Ganglion Block using 2% lidocaine |
| Group Prilocaine (P) | Experimental | Group P will receive 2ml of 4% prilocaine and 0.5ml saline Receives: Procedure: Sphenopalatine Ganglion Block |
| Group Prilocaine adrenaline (PA) | Experimental | Group PA will receive 2ml of 4% prilocaine and 0.5ml of diluted adrenaline. Receives: Procedure: Sphenopalatine Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAP
mean arterial blood pressure in the intraoperative period 5 minutes after nasal dissection
Measured: Mean arterial blood pressure in mmhg in the intraoperative period 5 minutes after nasal dissection
MAP
mean arterial blood presssure 5 minutes after nasal dissection
Measured: Mean arterial blood pressure in mmhg after 5 minutes of nasal dissection
Secondary outcomes (14)
Mean arterial blood pressure
Mean arterial blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Measured: Before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Systolic blood pressure
Systolic blood pressure before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Measured: Systolic blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Diastolic blood preesure
Diastolic blood pressure before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Measured: Diastolic blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
HR
Heart rate before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Measured: Heart rate in beats/min before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Patients needing propranolol
The number of patients needing propranolol in each group.
Measured: The number of patients throughout the study in the intraoperative period who received propranolol
Propranolol needed
The total amount of propranolol in mg used in each group
Measured: The amount of propranolol in mg used throughout the surgery in each group
Patients needing phentolamine
The number of patients needing phentolamine in each group.
Measured: The number of patients receiving phentolamine throughout the surgery in both groups
Phentolamine needed
The total amount of phentolamine in mg used in each group.
Measured: Throughout the surgical time from the begining to the end of surgery
Surgeon satisfaction scale
Surgeon satisfaction scale based on Average category scale (ACS) from 0 to 5 with 0 meaning no bleeding and 5 massive uncontrollable bleeding
Measured: 10 minutes after the end of surgery.
Time to 1st analgesic requirement
The time from emergence of anaesthesia till the request of first rescue analgesia
Measured: The time in hours from emergence of anaesthesia till the request of first rescue analgesia in the first 24 hours after surgery
Blood loss
The total ammount of blood loss in cc
Measured: Throughout the surgical time from the begining to the end of surgery
Requirement for transfusion
The number of patients requiring transfusion
Measured: Throughout the surgical time from the begining to the end of surgery
Fentanyl needed
number of patients needing fentanyl boluses intraoperatively
Measured: Throughout the surgical time from the begining to the end of surgery
Total amount of fentanyl
total ammount of fentanyl needed in micrograms
Measured: Throughout the surgical time from the begining to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood Pressure ControlStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Samir Fahmy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188987
- Sponsor's protocol ID
- MS- 403-2021
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The detailed protocol describing the techniques used in the study and the anesthetic conduct and the outcome measures. The statistical plan to analyze the different outcome measures.
Publications
Chaudhary R, Payal YS, Mohapatra B, Sony S, Shekhar S. USG-guided bilateral sphenopalatine ganglion block: A useful anesthetic adjuvant for trans nasal trans sphenoidal pituitary surgery in a patient with severely low ejection fraction. Saudi J Anaesth. 2025 Jan-Mar;19(1):102-104. doi: 10.4103/sja.sja_388_24. Epub 2025 Jan 1.
PubMed 39958315Rezaeian A, Hashemi SM, Dokhanchi ZS. Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Sinus Surgery. Allergy Rhinol (Providence). 2019 Jan 23;10:2152656718821282. doi: 10.1177/2152656718821282. eCollection 2019 Jan-Dec.
PubMed 30719401Cafiero T, Cavallo LM, Frangiosa A, Burrelli R, Gargiulo G, Cappabianca P, de Divitiis E. Clinical comparison of remifentanil-sevoflurane vs. remifentanil-propofol for endoscopic endonasal transphenoidal surgery. Eur J Anaesthesiol. 2007 May;24(5):441-6. doi: 10.1017/S0265021506002080. Epub 2007 Mar 12.
PubMed 17376252Jane JA Jr, Thapar K, Kaptain GJ, Maartens N, Laws ER Jr. Pituitary surgery: transsphenoidal approach. Neurosurgery. 2002 Aug;51(2):435-42; discussion 442-4.
PubMed 12182782
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Sphenopalatine Ganglion Block Using Prilocaine Versus Lidocaine as Adjuvants to General Anesthesia During Endoscopic Hypophysectomy, Randomized Trial.
- ClinicalTrials.gov ID
- NCT07188987
- Acronym / sponsor ID
- MS- 403-2021
- Conditions
- Blood Pressure Control
- Keywords
- Sphenopalatine ganglion block, Prilocaine, lidocaine, endoscopic hypophysectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 23 Sep 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.
Patients undergoing endoscopic surgeries for pituitary adenoma excision suffer from wide swings in blood pressure that might increase bleeding and interfere with the surgical field.
Local anethetic infiltration and regional nerve blocks have been used to provide better analgesia, control blood pressure and improve surgical field.
Limited studies evaluated shenopalatine ganglion block in pituitary adenoma excision with promising outcomes. The proposed study will compare the efficacy of two local anesthetics, prilocaine and lidocaine, for spenopalatine ganglion block in patients undergoing endoscopic pituitary adenoma excision. Evaluating the control of the intraoperative blood pressure and analgesic sparing are the main objectives of the proposed study.
Detailed description
Pituitary adenoma excision through endoscopic sinus surgery has been evolving over the years. Though less traumatic less traumatic and less invasive than other approaches, hemodynamic variations during several phases of the surgey as nasal dissection pose challenges for anesthesiologists.
Regional techniques present appealing options for better control of blood pressure during periods of maximal surgical stimulation, they may as well provide a better surgical field. One of the regional techniques is the sphenopalatine ganglion bock where a local anesthetic is injected in the pterygopalatine fossa around the sphenopalatine ganglion. Thus, It blocks pain transmission through the branches of the trigeminal nerve.
The current study was designed to compare the effects of two local anesthetics, lidocaine versus prilocaine on intraoperative hemodynamics, surgical field and analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Lidocaine (L) | Active comparator | Procedure: Sphenopalatine Ganglion Block using 2% lidocaineGroup L will receive 2ml of 2% lidocaine and 0.5ml of diluted adrenaline. |
| Group Prilocaine (P) | Experimental | Procedure: Sphenopalatine Ganglion BlockGroup P will receive 2ml of 4% prilocaine and 0.5ml saline |
| Group Prilocaine adrenaline (PA) | Experimental | Procedure: Sphenopalatine Ganglion BlockGroup PA will receive 2ml of 4% prilocaine and 0.5ml of diluted adrenaline. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with pituitary adenoma undergoing endoscopic hypophysectomy.
- ASA physical status I and II.
- Age above 21, below 45 years.
- Male or female
Key exclusion criteria (10 listed)
- Any patient below 21 years or above 45 years.
- Patients suffering from any of the following conditions:
- Patients on anticoagulants and/or NSAIDS (non-steroidal anti- inflammatory drugs
- Patients addicted to drugs and/or alcohol.
- Patients with disturbed conscious level at the end of the surgery, GCS >14
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 2% lidocaineSphenopalatine ganlion block with 2ml of 2% lidocaine and 0.5ml of diluted adrenaline after general anesthesia in patients undergoing enoscopic hypophysectomy. | Procedure or surgery | Group Lidocaine (L) |
| Sphenopalatine Ganglion BlockSphenopalatine ganlion block with will receive 2ml of 4% prilocaine and 0.5ml saline after general anesthesia in patients undergoing enoscopic hypophysectomy. | Procedure or surgery | Group Prilocaine (P) |
| Sphenopalatine Ganglion BlockSphenopalatine ganlion block with will receive 2ml of 4% prilocaine in addition to 0.5ml of diluted adrenaline. after general anesthesia in patients undergoing enoscopic hypophysectomy. | Procedure or surgery | Group Prilocaine adrenaline (PA) |
Primary outcome
MAP
Time frame: Mean arterial blood pressure in mmhg in the intraoperative period 5 minutes after nasal dissection
mean arterial blood pressure in the intraoperative period 5 minutes after nasal dissection
MAP
Time frame: Mean arterial blood pressure in mmhg after 5 minutes of nasal dissection
mean arterial blood presssure 5 minutes after nasal dissection
14 secondary outcomes
Mean arterial blood pressure
Time frame: Before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Systolic blood pressure
Time frame: Systolic blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Diastolic blood preesure
Time frame: Diastolic blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
HR
Time frame: Heart rate in beats/min before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.
Patients needing propranolol
Time frame: The number of patients throughout the study in the intraoperative period who received propranolol
Propranolol needed
Time frame: The amount of propranolol in mg used throughout the surgery in each group
Patients needing phentolamine
Time frame: The number of patients receiving phentolamine throughout the surgery in both groups
Phentolamine needed
Time frame: Throughout the surgical time from the begining to the end of surgery
Surgeon satisfaction scale
Time frame: 10 minutes after the end of surgery.
Time to 1st analgesic requirement
Time frame: The time in hours from emergence of anaesthesia till the request of first rescue analgesia in the first 24 hours after surgery
Blood loss
Time frame: Throughout the surgical time from the begining to the end of surgery
Requirement for transfusion
Time frame: Throughout the surgical time from the begining to the end of surgery
Fentanyl needed
Time frame: Throughout the surgical time from the begining to the end of surgery
Total amount of fentanyl
Time frame: Throughout the surgical time from the begining to the end of surgery
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 5 Dec 2025.
- Background: PubMed 39958315Chaudhary R, Payal YS, Mohapatra B, Sony S, Shekhar S. USG-guided bilateral sphenopalatine ganglion block: A useful anesthetic adjuvant for trans nasal trans sphenoidal pituitary surgery in a patient with severely low ejection fraction. Saudi J Anaesth. 2025 Jan-Mar;19(1):102-104. doi: 10.4103/sja.sja_388_24. Epub 2025 Jan 1.
- Background: PubMed 30719401Rezaeian A, Hashemi SM, Dokhanchi ZS. Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Sinus Surgery. Allergy Rhinol (Providence). 2019 Jan 23;10:2152656718821282. doi: 10.1177/2152656718821282. eCollection 2019 Jan-Dec.
- Background: PubMed 17376252Cafiero T, Cavallo LM, Frangiosa A, Burrelli R, Gargiulo G, Cappabianca P, de Divitiis E. Clinical comparison of remifentanil-sevoflurane vs. remifentanil-propofol for endoscopic endonasal transphenoidal surgery. Eur J Anaesthesiol. 2007 May;24(5):441-6. doi: 10.1017/S0265021506002080. Epub 2007 Mar 12.
- Background: PubMed 12182782Jane JA Jr, Thapar K, Kaptain GJ, Maartens N, Laws ER Jr. Pituitary surgery: transsphenoidal approach. Neurosurgery. 2002 Aug;51(2):435-42; discussion 442-4.
- Individual participant dataSharing planned: Yes. The detailed protocol describing the techniques used in the study and the anesthetic conduct and the outcome measures. The statistical plan to analyze the different outcome measures.
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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 2% lidocaine and Sphenopalatine Ganglion Block in people with Blood Pressure Control, run by Kasr El Aini Hospital 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 4 inclusion and 10 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 5 Dec 2025. 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 Rania Fahmy, Associate Professor (+201270820372, ransam98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAP (time frame: Mean arterial blood pressure in mmhg in the intraoperative period 5 minutes after nasal dissection). The study lists 2 primary outcomes in all. 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 NCT07188987, which also lists 4 linked publications.
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 5 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.