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Regional Anesthesia MorbidityNCT04697836

Cervical Plexus Block Combined With Translaryngeal Block for Tracheostomy

A study testing ST in people with Regional Anesthesia Morbidity, run by Namik Kemal University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Regional Anesthesia Morbidity
What is being tested?
ST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2020to 25 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Namık Kemal University

    Tekirdağ, Süleymanpaşa, 59100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
ST
Keywords
Regional Anesthesia, Tracheostomy, Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STProcedure or surgery

    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.

Study groups in NCT04697836
Study groupRoleWhat they receive
ST (superficial cervical plexus block combined with Translareyngeal block)ExperimentalSuperficial cervical plexus block combined with Translareyngeal block Group.
Receives: Procedure: ST
S (superficial cervical plexus block)Active comparatorSuperficial cervical plexus block Group
Receives: Procedure: ST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 hours

  2. 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

    Measured: 24 hours

  3. 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

    Measured: 24 hours

  4. cough and gag score

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

    Measured: 24 hours

  5. nausea and vomiting

    YES/NO

    Measured: 24 hours

  6. 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

    Measured: 24 hours from the pacu

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start1 Mar 2020
  3. Primary completion25 Nov 2020
  4. Study completion25 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
the new indication for cervical plexus block.
Masking
Single blind
Who is masked
Participant
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04697836
Sponsor's protocol ID
Regional anesthesia
Status last verified
Jan 2021
First submitted
25 Dec 2020
Last updated
6 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Demographic and clinical features of the study groups.

Publications

  • 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.

    PubMed 25955332

  • 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.

    PubMed 10229602

  • 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

  • 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.

    PubMed 16427530

  • 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.

    PubMed 29969890

Questions about this trial

What is this clinical trial studying?

A study testing ST in people with Regional Anesthesia Morbidity, run by Namik Kemal University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain score (NRS) (time frame: 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04697836, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.

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