Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04339231
• Other study ID #: Sphenopalatine
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 25, 2020
• Est. completion date: April 25, 2021

Study information

• Verified date: April 2020
• Source: Universidade Federal Fluminense
• Contact: Brynner M Bucard, Mr.
• Phone: +55 32 99943-5055
• Email: probrynner[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 25, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anesthesia, Local
• Pain, Postoperative
• Postoperative Pain
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto Estadual do Cérebro Paulo Niemeyer	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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; — View Citation

Kesimci E, Öztürk 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change the consumption of intraoperative opioids	Check the change in total opioid consumption in the intraoperative period	Intraoperative time
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative nausea and vomiting;	Check the incidence of postoperative nausea and vomiting	Immediately after awakening from anesthesia
Secondary	Postoperative nausea and vomiting;	Check the incidence of postoperative nausea and vomiting	2 hours postoperative
Secondary	Postoperative nausea and vomiting;	Check the incidence of postoperative nausea and vomiting	6 hours postoperative
Secondary	Postoperative nausea and vomiting;	Check the incidence of postoperative nausea and vomiting	12 hours postoperative
Secondary	Postoperative nausea and vomiting;	Check the incidence of postoperative nausea and vomiting	24 hours postoperative
Secondary	Postoperative headache	Check the incidence of postoperative headache	Immediately after awakening from anesthesia
Secondary	Postoperative headache	Check the incidence of postoperative headache	2 hours postoperative
Secondary	Postoperative headache	Check the incidence of postoperative headache	6 hours postoperative
Secondary	Postoperative headache	Check the incidence of postoperative headache	12 hours postoperative
Secondary	Postoperative headache	Check the incidence of postoperative headache	24 hours postoperative

External Links

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