Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-25

Study Completion Date

2021-04-25

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Surgery Anesthesia, Local Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

XXXXX

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

sphenopalatine ganglion block

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

sphenopalatine ganglion block

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes