Block of the Sphenopalatine Nerve Ganglion for Postoperative Analgesia

Not Applicable

• Conditions: Postoperative Pain; Surgery; Anesthesia, Local

• Registration Number: NCT04339231
• Lead Sponsor: Universidade Federal Fluminense

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).

Study Timeline

• Study First Submitted: 2020-03-31
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-05
• Study First Posted: 2020-04-09
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13
• Study Start: 2020-04-25
• Primary Completion: 2021-03-25
• Study Completion: 2021-04-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)	24 hours postoperative	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

Name	Time	Method
Use of complementary opioids	24 hours postoperative	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)
Change the consumption of intraoperative opioids	Intraoperative time	Check the change in total opioid consumption in the intraoperative period
Postoperative nausea and vomiting;	24 hours postoperative	Check the incidence of postoperative nausea and vomiting
Postoperative headache	24 hours postoperative	Check the incidence of postoperative headache

Trial Locations

Locations (1)

Instituto Estadual do Cérebro Paulo Niemeyer; 🇧🇷 Rio De Janeiro, Brazil