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Completed

NCT Number: NCT04697836

Cervical Plexus Block Combined With Translaryngeal Block for Tracheostomy

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.

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Key information

Conditions

Regional Anesthesia Morbidity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Namık Kemal University

Tekirdağ, Süleymanpaşa, 59100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. pain score (NRS)

    Time frame: 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

  2. pain related to incision

    Time frame: 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

  3. Patient tolerance as assessed by tracheostomy cannula comfort score

    Time frame: 24 hours

    • = No reaction
    • = Slight grimacing
    • = Heavy grimacing
    • = Defensive movement of hands 5= Flexion of the head with defense

  4. cough and gag score

    Time frame: 24 hours

    • = None
    • = Slight
    • = Moderate
    • = Severe

  5. nausea and vomiting

    Time frame: 24 hours

    YES/NO

  6. time to first analgesic demand

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Namik Kemal University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2021
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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