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Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia

Primary Purpose

Surgery, Anesthesia, Local, Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
sphenopalatine ganglion block
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring ropivacaine, sphenopalatine

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Instituto Estadual do Cérebro Paulo Niemeyer

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ropivacaine group

Saline 0,9% group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Change the consumption of intraoperative opioids
Check the change in total opioid consumption in the intraoperative period
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)
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)
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)
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)
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)
Postoperative nausea and vomiting;
Check the incidence of postoperative nausea and vomiting
Postoperative nausea and vomiting;
Check the incidence of postoperative nausea and vomiting
Postoperative nausea and vomiting;
Check the incidence of postoperative nausea and vomiting
Postoperative nausea and vomiting;
Check the incidence of postoperative nausea and vomiting
Postoperative nausea and vomiting;
Check the incidence of postoperative nausea and vomiting
Postoperative headache
Check the incidence of postoperative headache
Postoperative headache
Check the incidence of postoperative headache
Postoperative headache
Check the incidence of postoperative headache
Postoperative headache
Check the incidence of postoperative headache
Postoperative headache
Check the incidence of postoperative headache

Full Information

First Posted
March 31, 2020
Last Updated
April 9, 2020
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT04339231
Brief Title
Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia
Official Title
Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia in Transsphenoidal Approaches: a Prospective, Randomized and Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2020 (Anticipated)
Primary Completion Date
March 25, 2021 (Anticipated)
Study Completion Date
April 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Anesthesia, Local, Postoperative Pain
Keywords
ropivacaine, sphenopalatine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
XXXXX
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline 0,9% group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
sphenopalatine ganglion block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)
Description
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.
Time Frame
Immediately after awakening from anesthesia
Title
Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)
Description
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.
Time Frame
2 hours postoperative
Title
Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)
Description
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.
Time Frame
6 hours postoperative
Title
Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)
Description
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.
Time Frame
12 hours postoperative
Title
Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)
Description
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.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Change the consumption of intraoperative opioids
Description
Check the change in total opioid consumption in the intraoperative period
Time Frame
Intraoperative time
Title
Use of complementary opioids
Description
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)
Time Frame
Immediately after awakening from anesthesia
Title
Use of complementary opioids
Description
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)
Time Frame
2 hours postoperative
Title
Use of complementary opioids
Description
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)
Time Frame
6 hours postoperative
Title
Use of complementary opioids
Description
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)
Time Frame
12 hours postoperative
Title
Use of complementary opioids
Description
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)
Time Frame
24 hours postoperative
Title
Postoperative nausea and vomiting;
Description
Check the incidence of postoperative nausea and vomiting
Time Frame
Immediately after awakening from anesthesia
Title
Postoperative nausea and vomiting;
Description
Check the incidence of postoperative nausea and vomiting
Time Frame
2 hours postoperative
Title
Postoperative nausea and vomiting;
Description
Check the incidence of postoperative nausea and vomiting
Time Frame
6 hours postoperative
Title
Postoperative nausea and vomiting;
Description
Check the incidence of postoperative nausea and vomiting
Time Frame
12 hours postoperative
Title
Postoperative nausea and vomiting;
Description
Check the incidence of postoperative nausea and vomiting
Time Frame
24 hours postoperative
Title
Postoperative headache
Description
Check the incidence of postoperative headache
Time Frame
Immediately after awakening from anesthesia
Title
Postoperative headache
Description
Check the incidence of postoperative headache
Time Frame
2 hours postoperative
Title
Postoperative headache
Description
Check the incidence of postoperative headache
Time Frame
6 hours postoperative
Title
Postoperative headache
Description
Check the incidence of postoperative headache
Time Frame
12 hours postoperative
Title
Postoperative headache
Description
Check the incidence of postoperative headache
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both genders; Age between 18 and 64 years; Physical status according to the American Society of Anesthesiologists (ASA) I, II and III Saddle or suprasellar tumors with transsphenoidal access; Exclusion Criteria: Participation in another study in the last month; Patients with a history of chronic pain; Previous surgeries with a transsphenoidal approach; Known hypersensitivity to ropivacaine; Patient's refusal;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brynner M Bucard, Mr.
Phone
+55 32 99943-5055
Email
probrynner@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra R Assad, MD.
Phone
+55 21 99985-9746
Email
alexandraassad@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismar S Cavalcanti, MD.
Organizational Affiliation
Universidade Federal Fluminense
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Estadual do Cérebro Paulo Niemeyer
City
Rio De Janeiro
ZIP/Postal Code
20231-092
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brynner M Bucard, Mr.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share individual patient data
Citations:
PubMed Identifier
11765830
Citation
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.
Results Reference
result
PubMed Identifier
21739090
Citation
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.
Results Reference
result
PubMed Identifier
22287376
Citation
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.
Results Reference
result
Links:
URL
http://www.scielo.br/scielo.php?pid=S0034-72992007000400005&script=sci_abstract&tlng=pt
Description
Endoscopic transnasal approach to sellar tumors
URL
http://www.scielo.br/pdf/rba/v67n3/0034-7094-rba-67-03-0311.pdf
Description
Sphenopalatine ganglion block for postdural puncture headache in ambulatory setting
URL
http://scialert.net/fulltext/?doi=jms.2007.1297.1303
Description
Role of Intraoperative Endoscopic Sphenopalatine Ganglion Block in Sinonasal Surgery
URL
http://cyberleninka.org/article/n/444043/viewer
Description
Bilateral sphenopalatine ganglion block as adjuvant to general anaesthesia during endoscopic trans-nasal resection of pituitary adenoma

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Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia

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