Can Ultrasound-Guided Bilateral Cervical Plexus Block Combined With Translaryngeal Block For Tracheostomy Be An Alternative To General Anesthesia?
Phase: NA
Conditions: Regional Anesthesia Morbidity
Sponsor: Namik Kemal University

CLINICAL STUDY COVER PAGE  
 
Offıcial Study Title: Can Ultrasound-Guided Bilateral Cervical Plexus Block Combined With 
Translaryngeal Block For Tracheostomy Be An Alternative To General Anesthesia? 
 
Namık Kemal University ethics committee with the protocol number: 2020.240.10.08 
 
Namık Kemal University ethics committee approval date: October 27, 2020 
 
Address for correspondence: Dr. Ayhan ŞAHİN, 
 
Department of Anesthesiology and Reanimation, Medical Faculty of Namık Kemal University, 
Tekirdağ, Turkey 
 
Namık Kemal University Medicine Faculty, Anesthesiology Department, 2nd Floor, Tekirdağ, 
Süleymanpaşa, 59100, Turkey 
 
Phone number: 0905324730503 
 
E‐mail: drayhan.sahin@hotmail.com 
 
Co-authors: Ahmet GÜLTEKİN1, Gülcan GÜCER ŞAHİN2, İlker YILDIRIM1, Onur 
BARAN1, Tolga ERSÖZ3, M.Cavidan ARAR 
 
1Department of Anesthesiology and Reanimation, Medical Faculty of Namık Kemal 
University, Tekirdağ, Turkey 
2Department of Radiology, Medical Faculty of Namık Kemal University, Tekirdağ, Turkey 
3Department of Otolaryngology, Medical Faculty of Namık Kemal University, Tekirdağ, 
Turkey 
 
Background Information  
 
Study eligibility required that patients were 18-65 years of age, with American Society 
of Anesthesiology (ASA) classification I-III and scheduled for elective or emergency 
tracheostomy. Exclusion criteria were inability to cooperate, dementia, allergy to local 
anesthetics and opioids, regular daily opioid requirements, abuse of alcohol or medication, local 
infection at the site of injection or systemic infection, and pregnancy.  
 
After written informed consent, 29 subjects were enrolled at Namık Kemal University 
Hospital, Turkey. 
 
After a computer-generated randomization list with a 1:1 intergroup ratio, ensuring 
equal distribution in the two groups, 30 opaque sealed envelopes numbered 1–30 were prepared. 
The patients were randomly divided into the Group with bilateral CPB with 15 ml 0.5% 
bupivacaine or the patients with translaryngeal block with 5 ml 2% lidocaine in addition to 
bilateral CPB.  
 
Following inclusion, two research assistants, with no further involvement in the study, 
prepared 15mL syringes and 5 ml syringes according to the envelope's specifications. The 
syringes were marked with the patient's randomization number. All other investigators, staff, 

and patients were blinded to group allocations. Before surgery, the patients were transferred to 
the specified block room area monitored with 3-lead electrocardiography, pulse oximetry, and 
non-invasive blood pressure. All patients had two intravenous cannula lines, and then bilateral 
CPB block procedures were performed in awake non-sedated patients. 
 
All patients fasted for at least six hours before the surgery. Multichannel physiologic 
monitors were applied, and baseline hemodynamic variables (heart rate, systolic BP, diastolic 
BP, mean arterial pressure, SpO2, and ECG) were recorded. An intravenous line was 
established, and each patient received lactated Ringer's infusion. All patients were premedicated 
with midazolam 0,03 mg/kg just before the incision. All patients were kept monitored in the 
block room for at least 15 minutes after the block. 
 
 No additional sedation or additional local anesthetic was applied to the incision area 
during the operation. In the postoperative period, no additional analgesia was required in both 
the recovery unit and clinical follow-ups. 
 
Trial Purpose  
 
This study aims to assess the procedural comfort of the translaryngeal block combined 
with the cervical plexus block. According to our hypothesis, we thought that we would provide 
clinically significant comfort in tracheostomy cases with a cervical plexus block combined with 
a translaryngeal block. 
We have very well experienced in tracheostomy cases that the superficial cervical block 
provides sufficient anesthesia for the incision as it consists of sensitive branches of the cervical 
plexus. However, it does not affect the cough and the gag reflex in the patient while placing the 
tracheostomy cannula. Since otolaryngologists are often cautious about the incision in the 
trachea, inserting the cannula does not happen all at once. This almost always affects the 
comfort of the operation negatively.  
In tracheostomy patients, moving away from the general anesthesia option increases 
airway safety, and avoiding the local anesthesia option in the incision area increases patient 
comfort. 
 
Selection of Subjects  
Forty-two subjects were screened for eligibility from June 2020 to December 2020. 
Eleven patients did not meet inclusion criteria and two patients declined to participate. After 
informed consent 29 patients were enrolled and randomized. There were no differences in 
subject characteristics between groups.