Clinical trial · Interventional

Infraorbital Nerve Block for Endoscopic Transsphenoidal Approach to Remove Pituitary Tumor

The Effects of Infraorbital Nerve Block With Dexmedetomidine Added to Bupivacaine on Fentanyl Requirement During Endoscopic Transsphenoidal Approach to Remove Pituitary Tumor: Prospective Randomized Double Blinded Control Study

NCT04785222CI-TRIAL-00050500unknownPhase 4ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Intraoperative Pain Control	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
DB
description
Group DB: Bilateral infraorbital nerve block with dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine, in total volume of 2 ml per side
interventionNames
1. Drug: dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine
type
ACTIVE_COMPARATOR
label
BP
description
Group BP: Bilateral infraorbital nerve block with 0.5% plain bupivacaine, a volume of 2 ml per side
interventionNames
1. Drug: dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine
type
PLACEBO_COMPARATOR
label
NS
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

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

Exclusion Criteria:

* 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

References

Publications (6)

BACKGROUNDMariano 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
BACKGROUNDKaushal A, Haldar R. Regional Anesthesia in Neuroanesthesia Practice. Discoveries (Craiova). 2020 Jun 29;8(2):e111. doi: 10.15190/d.2020.8. PMID 32637571
BACKGROUNDEzzat 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
BACKGROUNDDunn 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
BACKGROUNDDimopoulou 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
DERIVEDPhothikun N, Pinon P, Saringkarinkul A, Polperm T, Plubnim N, Phothikun A. Effects of Infraorbital Nerve Block with Dexmedetomidine-Added Bupivacaine on Intraoperative Opioid Consumption and Postoperative Analgesia During Endoscopic Transsphenoidal Surgery: A Prospective, Randomized, Double-Blind Controlled Trial. J Pain Res. 2026 Apr 22;19:587111. doi: 10.2147/JPR.S587111. eCollection 2026. PMID 42046793