Clinical trial NCT04697836: Cervical Plexus Block Combined With Translaryngeal Block for Tracheostomy
Official title: Can Ultrasound-Guided Bilateral Cervical Plexus Block Combined With Translaryngeal Block For Tracheostomy Be An Alternative To General Anesthesia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia Morbidity
Keywords: Regional Anesthesia
Tracheostomy
Ultrasound
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the new indication for cervical plexus block.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Current healthcare delivery models emphasize enhanced postoperative recovery (ERAS) with minimal morbidity and shorter hospital stays. Most tracheostomy cases are tumour patients. The more the patients have difficulty in breathing, the more difficult it is to anaesthetize them. Adequate intraoperative anaesthesia and postoperative analgesia with minimal sedation play an essential role in this patient model. In tracheostomy patients, moving away from the general anaesthesia option increases airway safety, and avoiding the local anaesthesia option in the incision area increases patient comfort. The purpose of this study is to assess the safety and efficacy of regional anaesthesia in tracheostomy patients.

Detailed description: after being informed and about the study and potential risks, all patients giving written informed consent will undergo 24 hours screening period to determine the eligilibity for study entry. 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.

CPB: cervical plexus block.

Eligibility criteria: Inclusion Criteria:

* Being in the age range of 18-65, with American Society of Anesthesiology (ASA) classification I-III and scheduled for elective or emergency tracheostomy.
* A sufficient level of education to understand the study procedures and agree to participate in the study

Exclusion Criteria:

* 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,
* pregnancy.

Primary outcomes:
measure: pain score (NRS)
timeFrame: 24 hours
measure: pain related to incision
timeFrame: 24 hours
measure: Patient tolerance as assessed by tracheostomy cannula comfort score
timeFrame: 24 hours
measure: cough and gag score
timeFrame: 24 hours
measure: nausea and vomiting
timeFrame: 24 hours
measure: time to first analgesic demand
timeFrame: 24 hours from the pacu
Secondary outcomes:
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Namık Kemal University
state: Süleymanpaşa
Study officials:
affiliation: Clinical Director
name: AYHAN ŞAHİN
role: STUDY_DIRECTOR
References:
citation: Mehta AB, Syeda SN, Bajpayee L, Cooke CR, Walkey AJ, Wiener RS. Trends in Tracheostomy for Mechanically Ventilated Patients in the United States, 1993-2012. Am J Respir Crit Care Med. 2015 Aug 15;192(4):446-54. doi: 10.1164/rccm.201502-0239OC.
citation: Bradley PJ. Treatment of the patient with upper airway obstruction caused by cancer of the larynx. Otolaryngol Head Neck Surg. 1999 May;120(5):737-41. doi: 10.1053/hn.1999.v120.a90043.
citation: Freeman BD. Indications for and management of tracheostomy. In: Vincent JL, Abraham E, Moore FA, et al, editors. Textbook of critical care. 6th edition. Phila- delphia: Elsevier/W. B. Saunders; 2011. p. 369-72
citation: Moorthy SS, Gupta S, Laurent B, Weisberger EC. Management of airway in patients with laryngeal tumors. J Clin Anesth. 2005 Dec;17(8):604-9. doi: 10.1016/j.jclinane.2004.12.019.
citation: Kim JS, Ko JS, Bang S, Kim H, Lee SY. Cervical plexus block. Korean J Anesthesiol. 2018 Aug;71(4):274-288. doi: 10.4097/kja.d.18.00143. Epub 2018 Jul 4.