Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Transsphenoidal surgery is considered safe and effective and is currently the procedure of choice for the removal of intrasellar lesions. Direct transnasal access to the sphenoid sinus, without the need for detachment of the nasal septum, provides less postoperative morbidity compared to traditional methods. Sphenopalatine ganglion block is known for its efficacy in otorhinolaryngological surgeries in which the sinuses are approached by transnasal endoscopy, as an important part of postoperative analgesia. However, in a neurosurgical environment, specifically in the treatment of tumors of the sella turcica, the use of the blockade of the referred ganglion to produce postoperative analgesia has been used in a scarce way in the literature. The primary objective of the study is to verify whether blocking the sphenopalatine nerve ganglion in the nasopharynx posterior wall provides better postoperative pain control in surgeries with nasal access for transsphenoidal approach, compared to the placebo group. As secondary objectives, the investigators will observe the consumption of opioids in the intraoperative period, in addition to the incidence of nausea, vomiting and postoperative headache also within 24 hours. Forty patients with physical status P1, P2 or P3 will be prospectively analyzed by the American Society of Anesthesiology (ASA) to undergo microsurgery for tumors with a sellar and / or suprasellar location, with transsphenoidal access, in patients with an age range between 18 and 64 years old, including men and women.
Transsphenoidal surgery is considered safe and effective and is currently the procedure of choice for the removal of intrasellar lesions. Direct transnasal access to the sphenoid sinus, without the need for detachment of the nasal septum, provides less postoperative morbidity compared to traditional methods. Sphenopalatine ganglion block is known for its efficacy in otorhinolaryngological surgeries in which the sinuses are approached by transnasal endoscopy, as an important part of postoperative analgesia. However, in a neurosurgical environment, specifically in the treatment of tumors of the sella turcica, the use of the blockade of the referred ganglion to produce postoperative analgesia has been used in a scarce way in the literature. The primary objective of the study is to verify whether blocking the sphenopalatine nerve ganglion in the nasopharynx posterior wall provides better postoperative pain control in surgeries with nasal access for transsphenoidal approach, compared to the placebo group. As secondary objectives, the investigators will observe the consumption of opioids in the intraoperative period, in addition to the incidence of nausea, vomiting and postoperative headache also within 24 hours. Forty patients with physical status P1, P2 or P3 will be prospectively analyzed by the American Society of Anesthesiology (ASA) to undergo microsurgery for tumors with a sellar and / or suprasellar location, with transsphenoidal access, in patients with an age range between 18 and 64 years old, including men and women. As for the surgical technique, both the use of the microscope and the endoscope will be considered. They will be randomly allocated to a placebo group (group P; 0.9% saline, n = 20) and a test group (group R; ropivacaine 1%, n = 20).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine group | Active Comparator | The block of the sphenopalatine ganglion will be performed bilaterally through a cotton bud soaked with the anesthetic solution ropivacaine, at a concentration of 1%, advancing it through the nasal cavities towards the posterior nasopharynx wall. A slight resistance in the progression of the cottonoid indicates its contact with the mucosa of the posterior pharyngeal wall. The cottonoid will remain in this position for 20 minutes, so that there is absorption of the anesthetic solution through the mucosa up to the sphenopalatine ganglion, which, in general, is found anatomically around 3 millimeters in depth from the surface. After the established time, the cotton buds are removed. |
|
| Saline 0,9% group | Placebo Comparator | The block of the sphenopalatine ganglion will be performed bilaterally through a cotton bud soaked with saline solution, in a concentration of 0.9%, advancing it through the nasal cavities towards the posterior wall of the nasopharynx. A slight resistance in the progression of the cottonoid indicates its contact with the mucosa of the posterior pharyngeal wall. The cottonoid will remain in this position for 20 minutes, so that the solution is absorbed by the mucosa up to the sphenopalatine ganglion, which, in general, is anatomically three millimeters deep from the surface. After the established time, the cotton buds are removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sphenopalatine ganglion block | Procedure | The block of the sphenopalatine ganglion will be performed bilaterally, using a cotton bud soaked with 1% ropivacaine, placed in the mucosa of the posterior wall of the nasal cavity, through both nostrils. Once placed in the proper position, the swab will remain for about 20 minutes to absorb the local anesthetic from the mucosa. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain) | To verify whether blocking the sphenopalatine nerve ganglion in the posterior nasopharynx wall provides change in postoperative pain control, assessed using the visual analogue pain scale, in surgeries with nasal access for transsphenoidal approach, compared to the placebo group. | Immediately after awakening from anesthesia |
| Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain) | To verify whether blocking the sphenopalatine nerve ganglion in the posterior nasopharynx wall provides change in postoperative pain control, assessed using the visual analogue pain scale, in surgeries with nasal access for transsphenoidal approach, compared to the placebo group. | 2 hours postoperative |
| Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain) | To verify whether blocking the sphenopalatine nerve ganglion in the posterior nasopharynx wall provides change in postoperative pain control, assessed using the visual analogue pain scale, in surgeries with nasal access for transsphenoidal approach, compared to the placebo group. | 6 hours postoperative |
| Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain) | To verify whether blocking the sphenopalatine nerve ganglion in the posterior nasopharynx wall provides change in postoperative pain control, assessed using the visual analogue pain scale, in surgeries with nasal access for transsphenoidal approach, compared to the placebo group. | 12 hours postoperative |
| Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain) | To verify whether blocking the sphenopalatine nerve ganglion in the posterior nasopharynx wall provides change in postoperative pain control, assessed using the visual analogue pain scale, in surgeries with nasal access for transsphenoidal approach, compared to the placebo group. |
| Measure | Description | Time Frame |
|---|---|---|
| Change the consumption of intraoperative opioids | Check the change in total opioid consumption in the intraoperative period | Intraoperative time |
| Use of complementary opioids | Assess the number of rescue doses with opioids in pos operative period for for adequate analgesia (it is understood as insufficient analgesia classification on the visual analog scale of pain greater than or equal to 3) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brynner M Bucard, Mr. | Contact | +55 32 99943-5055 | probrynner@hotmail.com | |
| Alexandra R Assad, MD. | Contact | +55 21 99985-9746 | alexandraassad@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ismar S Cavalcanti, MD. | Universidade Federal Fluminense | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Estadual do Cérebro Paulo Niemeyer | Rio de Janeiro | 20231-092 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11765830 | Result | Liu JK, Das K, Weiss MH, Laws ER Jr, Couldwell WT. The history and evolution of transsphenoidal surgery. J Neurosurg. 2001 Dec;95(6):1083-96. doi: 10.3171/jns.2001.95.6.1083. | |
| 21739090 | Result | Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8. |
| Label | URL |
|---|---|
| Endoscopic transnasal approach to sellar tumors | View source |
Not provided
There are no plans to share individual patient data
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2019 | Mar 31, 2020 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
Not provided
Not provided
XXXXX
Not provided
Not provided
Not provided
|
| 24 hours postoperative |
| Immediately after awakening from anesthesia |
| Use of complementary opioids | Assess the number of rescue doses with opioids in pos operative period for for adequate analgesia (it is understood as insufficient analgesia classification on the visual analog scale of pain greater than or equal to 3) | 2 hours postoperative |
| Use of complementary opioids | Assess the number of rescue doses with opioids in pos operative period for for adequate analgesia (it is understood as insufficient analgesia classification on the visual analog scale of pain greater than or equal to 3) | 6 hours postoperative |
| Use of complementary opioids | Assess the number of rescue doses with opioids in pos operative period for for adequate analgesia (it is understood as insufficient analgesia classification on the visual analog scale of pain greater than or equal to 3) | 12 hours postoperative |
| Use of complementary opioids | Assess the number of rescue doses with opioids in pos operative period for for adequate analgesia (it is understood as insufficient analgesia classification on the visual analog scale of pain greater than or equal to 3) | 24 hours postoperative |
| Postoperative nausea and vomiting; | Check the incidence of postoperative nausea and vomiting | Immediately after awakening from anesthesia |
| Postoperative nausea and vomiting; | Check the incidence of postoperative nausea and vomiting | 2 hours postoperative |
| Postoperative nausea and vomiting; | Check the incidence of postoperative nausea and vomiting | 6 hours postoperative |
| Postoperative nausea and vomiting; | Check the incidence of postoperative nausea and vomiting | 12 hours postoperative |
| Postoperative nausea and vomiting; | Check the incidence of postoperative nausea and vomiting | 24 hours postoperative |
| Postoperative headache | Check the incidence of postoperative headache | Immediately after awakening from anesthesia |
| Postoperative headache | Check the incidence of postoperative headache | 2 hours postoperative |
| Postoperative headache | Check the incidence of postoperative headache | 6 hours postoperative |
| Postoperative headache | Check the incidence of postoperative headache | 12 hours postoperative |
| Postoperative headache | Check the incidence of postoperative headache | 24 hours postoperative |
| 22287376 | Result | Cho DY, Drover DR, Nekhendzy V, Butwick AJ, Collins J, Hwang PH. The effectiveness of preemptive sphenopalatine ganglion block on postoperative pain and functional outcomes after functional endoscopic sinus surgery. Int Forum Allergy Rhinol. 2011 May-Jun;1(3):212-8. doi: 10.1002/alr.20040. Epub 2011 Apr 13. |
| CT of the sella turcica after transsphenoidal resection of pituitary adenomas | View source |
| Sphenopalatine ganglion block for postdural puncture headache in ambulatory setting | View source |
| Role of Intraoperative Endoscopic Sphenopalatine Ganglion Block in Sinonasal Surgery | View source |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000760 |
| Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |