Cervical Plexus Block Combined With Translaryngeal Block for Tracheostomy

Regional Anesthesia Morbidity Clinical Trial

Official title:

Can Ultrasound-Guided Bilateral Cervical Plexus Block Combined With Translaryngeal Block For Tracheostomy Be An Alternative To General Anesthesia?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697836
• Other study ID #: Regional anesthesia
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: November 25, 2020

Study information

• Verified date: January 2021
• Source: Namik Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity

Intervention

Procedure:
• ST
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.

Locations

Country	Name	City	State
Turkey	Namik Kemal University	Tekirdag	Süleymanpasa

Sponsors (1)

Lead Sponsor	Collaborator
Namik Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. Review. — View 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

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. — View 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. — View 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. Erratum in: J Clin Anesth. 2006 Mar;18(2):163-4. PMID: 16427530

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score (NRS)	A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable	24 hours
Primary	pain related to incision	A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable	24 hours
Primary	Patient tolerance as assessed by tracheostomy cannula comfort score	= No reaction; = Slight grimacing; = Heavy grimacing; = Defensive movement of hands 5= Flexion of the head with defense	24 hours
Primary	cough and gag score	= None; = Slight; = Moderate; = Severe	24 hours
Primary	nausea and vomiting	YES/NO	24 hours
Primary	time to first analgesic demand	Time of first analgesic need within the first 24 hours 0: within the first 12 hours; 1: 12-24 hours	24 hours from the pacu