Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia

Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia in Transsphenoidal Approaches: a Prospective, Randomized and Double-blind Study

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Anesthesia, Local; Surgery
• Intervention / Treatment: Procedure: sphenopalatine ganglion block

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 20231-092
    • Instituto Estadual do Cérebro Paulo Niemeyer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Both genders;
2. Age between 18 and 64 years;
3. Physical status according to the American Society of Anesthesiologists (ASA) I, II and III
4. Saddle or suprasellar tumors with transsphenoidal access;

Exclusion Criteria:

1. Participation in another study in the last month;
2. Patients with a history of chronic pain;
3. Previous surgeries with a transsphenoidal approach;
4. Known hypersensitivity to ropivacaine;
5. Patient's refusal;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ropivacaine group; 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.	Procedure: sphenopalatine ganglion block; 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.
Placebo Comparator: Saline 0,9% group; 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.	Procedure: sphenopalatine ganglion block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Investigators: Study Chair: Ismar S Cavalcanti, MD., Universidade Federal Fluminense

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Endoscopic transnasal approach to sellar tumors
• CT of the sella turcica after transsphenoidal resection of pituitary adenomas
• Sphenopalatine ganglion block for postdural puncture headache in ambulatory setting
• Role of Intraoperative Endoscopic Sphenopalatine Ganglion Block in Sinonasal Surgery
• Bilateral sphenopalatine ganglion block as adjuvant to general anaesthesia during endoscopic trans-nasal resection of pituitary adenoma

Study record dates

Study Major Dates

• Study Start (Anticipated): April 25, 2020
• Primary Completion (Anticipated): March 25, 2021
• Study Completion (Anticipated): April 25, 2021

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 5, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: ropivacaine; sphenopalatine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Sphenopalatine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There are no plans to share individual patient data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No