Infraorbital Nerve Block for Endoscopic Transsphenoidal Approach to Remove Pituitary Tumor
Primary Purpose
Intraoperative Pain Control
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Intraoperative Pain Control focused on measuring Infraorbital nerve block, Endoscopic Transsphenoid Approach, Pituitary tumors
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
DB
BP
NS
Arm 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
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
Outcomes
Primary Outcome Measures
The total fentanyl used (mcg) during the endoscopic transsphenoidal pituitary surgery.
fentanyl administered iv during surgery according to the criteria of vital sign changes
Secondary Outcome Measures
Time to the second dose of i.v. fentanyl
after the first dose of fentanyl given in all patients, the duration for the second dose according to the vital sign changes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04785222
Brief Title
Infraorbital Nerve Block for Endoscopic Transsphenoidal Approach to Remove Pituitary Tumor
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Infraorbital nerve- The infraorbital nerve exits from the infraorbital foramen. It is a branch of the maxillary nerve, the second division of the trigeminal nerve, the fifth cranial nerve. The infraorbital nerve is a pure sensory nerve innervates the lateral aspect of the nose, upper lip, upper incisor, canines, premolars, and the first molar of the ipsilateral side. (1-6) The NYSORA website mentions that 'transsphenoidal hypophysectomy' is one of the indications of infraorbital nerve block. (2) There are two approaches to block this nerve, the intraoral and extraoral approaches. Regardless to the approach, the infraorbital foramen must be palpated throughout the procedure to avoid the serious complication of eyeball penetration. (2,4,6) This study, we use the extraoral approach with a 27-gauge needle advance perpendicularly toward the foramen. When the bony resistance is appreciated, slowly injects 2 ml of local anesthetics. After the injection, gently massage over the puncture site to prevent the hematoma formation. (2)
Pituitary adenomas- Pituitary adenomas are the tumors of the pituitary gland. The tumors can be classified by the size and/ or by the functional status of hormone production. Dimension < 1 cm is microadenoma and dimension ≥ 1 cm is called macroadenoma. (7) Treatment options for pituitary tumors are surgery, radiation, and medications. The single or combination of treatment depends on types of tumor, its size, how fast the tumor grows, patient's age, and patient's general condition. (8) The two main surgical techniques for removing pituitary tumors are endoscopic trans-nasal transsphenoidal (ETSS) approach and transcranial or craniotomy approach. The transsphenoidal approach has many advantages such as less brain tissue damage than those in craniotomy approach. There is no visible scar because a small incision will be done over the nasal septum and through the sphenoid sinus. The bony posterior wall of sphenoid sinus is drilled with small surgical chisels to reach the pituitary gland. (9) Choice of anesthesia for ETSS approach is general anesthesia with cuffed endotracheal intubation strap over the left corner of patient's mouth. Balanced anesthetic technique is maintained throughout the surgical procedure. Specific goals for ETSS pituitary surgery are optimized hormonal function, facilitate surgical exposure, surveillance and promptly treatment for massive bleeding from accidentally penetration to the cavernous sinus. General goals for neurosurgery are maintain the hemodynamic stability and rapid emergence. (10) Promoting selective nerve block instead of systemic opioid analgesics, we anticipate to see a rapid wear off from general anesthesia and rapid awakening.
Characteristics of pain in pituitary adenomas - A cross-sectional study of 278 patients with pituitary adenomas was shown that i) the prevalence of somatic pain (called 'bodily pain' in the study) was high and independent to the tumor type, ii) the patients diagnosed of Cushing's disease were more susceptible to pain than the patients diagnosed of other pituitary diseases, iii) a high incidence of headache which is independent to the tumor type, and iv) pain significantly correlated to depression and quality of life (QoL).(11,12) Pituitary tumor headache was reported unilaterally, at the site of orbital and retro-orbital, and throbbing in quality. Its severity was moderate to strong. (12) According to International Headache Society (IHS), pituitary tumor caused chronic and episodic migraine, 46% and 30%, respectively. (13,14) These findings demonstrate the importance of adequate pain relieve during pituitary surgery while rapid awakening after general anesthesia is required.
Dexmedetomidine addition to bupivacaine - Addition of dexmedetomidine to bupivacaine in greater palatine nerve block and supra-zygomatic maxillary nerve block was resulted prolong the analgesic duration, decrease postoperative analgesic requirement, and no additional side effects such as hemodynamic disturbance and sedation. (15,16) The reported dosage was 0.5-1 µg/kg of dexmedetomidine. A systematic review of nine RCTs revealed many positive effects of dexmedetomidine in facilitating neuraxial and peripheral nerve block. (16) Dexmedetomidine-related adverse effects were transient bradycardia in brachial plexus block but did not observe in intrathecal administration. Respiratory depression was not seen. A high dosage of dexmedetomidine (15 µg) administered intrathecally caused higher sedation level during surgery. (17) The result from this study will add more evidence of the use of perineural dexmedetomidine in clinical setting.
Materials and methods Study hypothesis: We hypothesize that the bilateral infraorbital nerve block with dexmedetomidine added to bupivacaine reduce fentanyl used during endoscopic transsphenoidal pituitary surgery.
Study design: Prospective randomized double blinded control (patients and assessors will be blinded) Participants: Adult patients, age ≥ 18 years old, diagnosis of pituitary tumor, scheduled for endoscopic transsphenoidal approach to remove tumor under general anesthesia with endotracheal tube.
The exclusion criteria will be 1) the patient is known case of allergy to dexmedetomidine, 2) the patient allergy to bupivacaine, 3) the patient does not sign a consent form to participate to the study, 4) the operation is changed due to cavernous sinus perforation, 5) the navigator and Mayfield is used to identify the tumor There are no pre-specified withdrawal criteria. The expected duration of subject participation is 3 days including the surgical day, which is day-1. At the time of pre-surgical evaluation and informed consent, participants will be informed that their participation in this research is voluntary and they may discontinue participation without consequence at any time. The data obtained prior to the subject's decision of withdrawal will be retained and analyzed in consistent with the study purpose. Unless the participants indicate that they want to remove their data from the study.
Ethical consideration: Before commencement of the study, the research proposal must be approved by the Ethical Committee (EC) of Faculty of Medicine, Chiang Mai University (CMU). The protocol will be registered to the Research Operation System (ROS) and the website www.clinicaltrial.gov. Participants of this study should be fully level of conscious, E4V5M6. The research team will explain the procedure and risks to the participants one day prior to the surgery. If the participants decide to be enrolled, the consent form will be asked to sign.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Pain Control
Keywords
Infraorbital nerve block, Endoscopic Transsphenoid Approach, Pituitary tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DB
Arm Type
Experimental
Arm 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
Arm Title
BP
Arm Type
Active Comparator
Arm Description
Group BP: Bilateral infraorbital nerve block with 0.5% plain bupivacaine, a volume of 2 ml per side
Arm Title
NS
Arm Type
Placebo Comparator
Arm Description
Group NS (control): Bilateral infraorbital nerve block with normal saline 2 ml per side
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine
Other Intervention Name(s)
DB
Intervention Description
Bilateral infraorbital nerve block with dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine, in total volume of 2 ml per side
Primary Outcome Measure Information:
Title
The total fentanyl used (mcg) during the endoscopic transsphenoidal pituitary surgery.
Description
fentanyl administered iv during surgery according to the criteria of vital sign changes
Time Frame
in operating room during surgery
Secondary Outcome Measure Information:
Title
Time to the second dose of i.v. fentanyl
Description
after the first dose of fentanyl given in all patients, the duration for the second dose according to the vital sign changes
Time Frame
during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pathomporn Pinon, MD
Phone
01166868970009
Email
pinon.pathomporn@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19475468
Citation
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.
Results Reference
background
PubMed Identifier
32637571
Citation
Kaushal A, Haldar R. Regional Anesthesia in Neuroanesthesia Practice. Discoveries (Craiova). 2020 Jun 29;8(2):e111. doi: 10.15190/d.2020.8.
Results Reference
background
PubMed Identifier
15274075
Citation
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.
Results Reference
background
PubMed Identifier
23963232
Citation
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.
Results Reference
background
PubMed Identifier
25117460
Citation
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.
Results Reference
background
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Infraorbital Nerve Block for Endoscopic Transsphenoidal Approach to Remove Pituitary Tumor
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