Infraorbital Nerve Block for Endoscopic Transsphenoidal Approach to Remove Pituitary Tumor

NCT04785222 | Unknown Phase 4 DMC

• 1 other identifier: ANE_04032021
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

Perioperative pain relief during endoscopic transsphenoidal pituitary surgery is generally treated with opioids either morphine sulfate or fentanyl. This study will compare the traditional method of intravenous fentanyl to the bilateral infraorbital nerve block in adult patients scheduled for pituitary surgery by the transsphenoidal approach.

Conditions

Intraoperative Pain Control

Keywords

Infraorbital nerve block; Endoscopic Transsphenoid Approach; Pituitary tumors

Outcome Measures

Primary Outcomes (1)

• The total fentanyl used (mcg) during the endoscopic transsphenoidal pituitary surgery.

  fentanyl administered iv during surgery according to the criteria of vital sign changes

  in operating room during surgery

Secondary Outcomes (1)

• Time to the second dose of i.v. fentanyl

  during surgery

Study Arms (3)

DB

EXPERIMENTAL

Group DB: Bilateral infraorbital nerve block with dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine, in total volume of 2 ml per side

Drug: dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine

BP

ACTIVE COMPARATOR

Group BP: Bilateral infraorbital nerve block with 0.5% plain bupivacaine, a volume of 2 ml per side

Drug: dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine

NS

PLACEBO COMPARATOR

Group NS (control): Bilateral infraorbital nerve block with normal saline 2 ml per side

Drug: dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine

Interventions

dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine DRUG

Bilateral infraorbital nerve block with dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine, in total volume of 2 ml per side

Also known as: DB

BP; DB; NS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• age ≥ 18 years old
• diagnosis of pituitary tumor
• scheduled for endoscopic transsphenoidal approach to remove tumor under general anesthesia with endotracheal tube

You may not qualify if:

• the patient is known case of allergy to dexmedetomidine
• the patient allergy to bupivacaine
• the patient does not sign a consent form to participate to the study
• the operation is changed due to cavernous sinus perforation
• the navigator and Mayfield is used to identify the tumor

Sponsors & Collaborators

• Chiang Mai University: lead

Related Publications (5)

• Mariano ER, Watson D, Loland VJ, Chu LF, Cheng GS, Mehta SH, Maldonado RC, Ilfeld BM. Bilateral infraorbital nerve blocks decrease postoperative pain but do not reduce time to discharge following outpatient nasal surgery. Can J Anaesth. 2009 Aug;56(8):584-9. doi: 10.1007/s12630-009-9119-5. Epub 2009 May 28.

  PMID: 19475468 BACKGROUND

• Kaushal A, Haldar R. Regional Anesthesia in Neuroanesthesia Practice. Discoveries (Craiova). 2020 Jun 29;8(2):e111. doi: 10.15190/d.2020.8.

  PMID: 32637571 BACKGROUND

• Ezzat S, Asa SL, Couldwell WT, Barr CE, Dodge WE, Vance ML, McCutcheon IE. The prevalence of pituitary adenomas: a systematic review. Cancer. 2004 Aug 1;101(3):613-9. doi: 10.1002/cncr.20412.

  PMID: 15274075 BACKGROUND

• Dunn LK, Nemergut EC. Anesthesia for transsphenoidal pituitary surgery. Curr Opin Anaesthesiol. 2013 Oct;26(5):549-54. doi: 10.1097/01.aco.0000432521.01339.ab.

  PMID: 23963232 BACKGROUND

• Dimopoulou C, Athanasoulia AP, Hanisch E, Held S, Sprenger T, Toelle TR, Roemmler-Zehrer J, Schopohl J, Stalla GK, Sievers C. Clinical characteristics of pain in patients with pituitary adenomas. Eur J Endocrinol. 2014 Nov;171(5):581-91. doi: 10.1530/EJE-14-0375. Epub 2014 Aug 12.

  PMID: 25117460 BACKGROUND

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Pathomporn Pinon, MD

CONTACT

01166868970009; pinon.pathomporn@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outside of the envelope is an individual code (e.g., IC2, CY1). Inside an envelope is a group (DB, BP, or NS). A nurse will prepare local anesthetics in a two 3-ml syringe and put them in the envelope according to the allocation order. The syringe will be containing the same volume of clear drugs which are unable to be distinguished between groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention and group assignment: The subjects will be randomized into three groups, as following. Group DB: Bilateral infraorbital nerve block with dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine, in total volume of 2 ml per side Group BP: Bilateral infraorbital nerve block with 0.5% plain bupivacaine, a volume of 2 ml per side Group NS (control): Bilateral infraorbital nerve block with normal saline 2 ml per side

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share