Regional Anesthesia Morbidity
Conditions
Keywords
Regional Anesthesia, Tracheostomy, Ultrasound
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.
Interventions
PROCEDUREST
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.
Sponsors
Namik Kemal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
the new indication for cervical plexus block.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed