Cervical Plexus Block Combined With Translaryngeal Block for Tracheostomy

Not Applicable

Completed

• Conditions: Regional Anesthesia Morbidity
• Interventions: Procedure: ST

• Registration Number: NCT04697836
• Lead Sponsor: Namik Kemal University

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.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-11-25
• Study Completion: 2020-11-25
• Study First Submitted: 2020-12-25
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-04
• Last Update Submitted: 2021-01-04
• Study First Posted: 2021-01-06
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ST (superficial cervical plexus block combined with Translareyngeal block)	ST	Superficial cervical plexus block combined with Translareyngeal block Group.
S (superficial cervical plexus block)	ST	Superficial cervical plexus block Group

Primary Outcome Measures

Name	Time	Method
pain score (NRS)	24 hours	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
pain related to incision	24 hours	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
nausea and vomiting	24 hours	YES/NO
time to first analgesic demand	24 hours from the pacu	Time of first analgesic need within the first 24 hours 0: within the first 12 hours; 1: 12-24 hours
Patient tolerance as assessed by tracheostomy cannula comfort score	24 hours	1. = No reaction; 2. = Slight grimacing; 3. = Heavy grimacing; 4. = Defensive movement of hands 5= Flexion of the head with defense
cough and gag score	24 hours	1. = None; 2. = Slight; 3. = Moderate; 4. = Severe

Trial Locations

Locations (1)

Namık Kemal University; 🇹🇷 Tekirdağ, Süleymanpaşa, Turkey