Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04785222 |
| Other study ID # |
ANE_04032021 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 2021 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
March 2021 |
| Source |
Chiang Mai University |
| Contact |
Pathomporn Pinon, MD |
| Phone |
01166868970009 |
| Email |
pinon.pathomporn[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
1. 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)
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.
3. 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.
4. 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.
