An interventional study of ST in Regional Anesthesia Morbidity, sponsored by Namik Kemal University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-06.
Sponsored by Namik Kemal University · Not applicable, Interventional, and Supportive care
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.
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.
Namik Kemal University is the lead sponsor of 57 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Superficial cervical plexus block combined with Translareyngeal block Group.
Procedure: ST
Superficial cervical plexus block Group
Procedure: ST
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.
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
Time frame: 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
Time frame: 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
Time frame: 24 hours
cough and gag score
1. = None 2. = Slight 3. = Moderate 4. = Severe
Time frame: 24 hours
nausea and vomiting
YES/NO
Time frame: 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
Time frame: 24 hours from the pacu
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Demographic and clinical features of the study groups.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Namik Kemal University