Cervical Plexus Block Combined With Translaryngeal Block for Tracheostomy

NCT04697836 | Completed

• 1 other identifier: Regional anesthesia
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia Morbidity

Keywords

Regional Anesthesia; Tracheostomy; Ultrasound

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Patient tolerance as assessed by tracheostomy cannula comfort score

  1. = No reaction 2. = Slight grimacing 3. = Heavy grimacing 4. = Defensive movement of hands 5= Flexion of the head with defense

  24 hours

• cough and gag score

  1. = None 2. = Slight 3. = Moderate 4. = Severe

  24 hours

• nausea and vomiting

  YES/NO

  24 hours

• 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

Study Arms (2)

ST (superficial cervical plexus block combined with Translareyngeal block)

EXPERIMENTAL

Superficial cervical plexus block combined with Translareyngeal block Group.

Procedure: ST

S (superficial cervical plexus block)

ACTIVE COMPARATOR

Superficial cervical plexus block Group

Procedure: ST

Interventions

ST PROCEDURE

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.

S (superficial cervical plexus block); ST (superficial cervical plexus block combined with Translareyngeal block)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Namık Kemal University

Tekirdağ, Süleymanpaşa, 59100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 25955332 BACKGROUND

• 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.

  PMID: 10229602 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16427530 BACKGROUND

• 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.

  PMID: 29969890 BACKGROUND

Study Officials

• AYHAN ŞAHİN

  Clinical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Prof

Model Details: the new indication for cervical plexus block.

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: January 6, 2021
• Study Start: March 1, 2020
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: study is finished
• Access Criteria: public

Locations

TU (1)