Clinical trial NCT04339231: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Anesthesia, Local
Postoperative Pain
Keywords: ropivacaine
sphenopalatine
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: XXXXX
Primary purpose: TREATMENT

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).

Eligibility criteria: 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;

Primary outcomes:
measure: Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)
timeFrame: Immediately after awakening from anesthesia
measure: Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)
timeFrame: 2 hours postoperative
measure: Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)
timeFrame: 6 hours postoperative
measure: Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)
timeFrame: 12 hours postoperative
measure: Evaluation of postoperative analgesia using the visual analogue pain scale (VAS pain)
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Change the consumption of intraoperative opioids
timeFrame: Intraoperative time
measure: Use of complementary opioids
timeFrame: Immediately after awakening from anesthesia
measure: Use of complementary opioids
timeFrame: 2 hours postoperative
measure: Use of complementary opioids
timeFrame: 6 hours postoperative
measure: Use of complementary opioids
timeFrame: 12 hours postoperative
measure: Use of complementary opioids
timeFrame: 24 hours postoperative
measure: Postoperative nausea and vomiting;
timeFrame: Immediately after awakening from anesthesia
measure: Postoperative nausea and vomiting;
timeFrame: 2 hours postoperative
measure: Postoperative nausea and vomiting;
timeFrame: 6 hours postoperative
measure: Postoperative nausea and vomiting;
timeFrame: 12 hours postoperative
measure: Postoperative nausea and vomiting;
timeFrame: 24 hours postoperative
measure: Postoperative headache
timeFrame: Immediately after awakening from anesthesia
measure: Postoperative headache
timeFrame: 2 hours postoperative
measure: Postoperative headache
timeFrame: 6 hours postoperative
measure: Postoperative headache
timeFrame: 12 hours postoperative
measure: Postoperative headache
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Instituto Estadual do Cérebro Paulo Niemeyer
Study officials:
affiliation: Universidade Federal Fluminense
name: Ismar S Cavalcanti, MD.
role: STUDY_CHAIR
References:
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.
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.
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.