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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Lidocaine (L) | Active Comparator | Group L will receive 2ml of 2% lidocaine and 0.5ml of diluted adrenaline. |
|
| Group Prilocaine (P) | Experimental | Group P will receive 2ml of 4% prilocaine and 0.5ml saline |
|
| Group Prilocaine adrenaline (PA) | Experimental | Group PA will receive 2ml of 4% prilocaine and 0.5ml of diluted adrenaline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphenopalatine Ganglion Block using 2% lidocaine | Procedure | Sphenopalatine ganlion block with 2ml of 2% lidocaine and 0.5ml of diluted adrenaline after general anesthesia in patients undergoing enoscopic hypophysectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| MAP | mean arterial blood pressure in the intraoperative period 5 minutes after nasal dissection | 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 | Mean arterial blood pressure in mmhg after 5 minutes of nasal dissection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rania Fahmy, Associate Professor | Contact | +201270820372 | ransam98@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr El Ainy | Recruiting | Cairo | 11956 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39958315 | Background | 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. | |
| 30719401 |
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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.
IPD can be available 3 months after completion of the study
IPD can be accessed from the authors by journals considering the study for publication and upon reasonable request from other investigators
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D059387 | Sphenopalatine Ganglion Block |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Sphenopalatine Ganglion Block | Procedure | Sphenopalatine ganlion block with will receive 2ml of 4% prilocaine and 0.5ml saline after general anesthesia in patients undergoing enoscopic hypophysectomy. |
|
| Sphenopalatine Ganglion Block | Procedure | 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. |
|
| 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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 | 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 | 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 | Throughout the surgical time from the begining to the end of surgery |
| Requirement for transfusion | The number of patients requiring transfusion | Throughout the surgical time from the begining to the end of surgery |
| Fentanyl needed | number of patients needing fentanyl boluses intraoperatively | Throughout the surgical time from the begining to the end of surgery |
| Total amount of fentanyl | total ammount of fentanyl needed in micrograms | Throughout the surgical time from the begining to the end of surgery |
| Rezaeian 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. |
| 17376252 | Background | Cafiero 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. |
| 12182782 | Background | Jane 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. |
| Aniline Compounds |
| D000588 | Amines |
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |