Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia

NCT04339231 | Unknown

• 1 other identifier: Sphenopalatine
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Anesthesia, Local; Postoperative Pain

Keywords

ropivacaine; sphenopalatine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (16)

• Change the consumption of intraoperative opioids

  Intraoperative time

• Use of complementary opioids

  Immediately after awakening from anesthesia

• Use of complementary opioids

  2 hours postoperative

• Use of complementary opioids

  6 hours postoperative

• Use of complementary opioids

  12 hours postoperative

Study Arms (2)

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.

Procedure: sphenopalatine ganglion block

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.

Procedure: sphenopalatine ganglion block

Interventions

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.

Ropivacaine group; Saline 0,9% group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Instituto Estadual do Cérebro Paulo Niemeyer

Rio de Janeiro, 20231-092, Brazil

Location

Related Publications (3)

• 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.

  PMID: 11765830 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.

  PMID: 21739090 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.

  PMID: 22287376 RESULT

Related 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

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Ismar S Cavalcanti, MD.

  Universidade Federal Fluminense

  STUDY CHAIR

Central Study Contacts

Brynner M Bucard, Mr.

CONTACT

+55 32 99943-5055; probrynner@hotmail.com

Alexandra R Assad, MD.

CONTACT

+55 21 99985-9746; alexandraassad@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: XXXXX

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 9, 2020
• Study Start: April 25, 2020
• Primary Completion: March 25, 2021
• Study Completion: April 25, 2021
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)