Tracheostomy
Conditions
Keywords
local infiltration, bilateral superficial cervical plexus block, lidocaine, bupivacaine, substance-p
Brief summary
The aim of this study was to compare the efficacy between superficial cervical plexus block and local infiltration of lidocaine 2% in patients undergoing tracheostomy procedure.
Detailed description
Ethical approval was obtained from Ethics Committee of Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo Hospital. Eligible subjects for this study will be recruited with consecutive sampling method within certain period until minimum number of subjects required for this study is filled. Informed consents will be given to each subject before participating in the study. Patients will be randomly divided into two groups using closed envelops. Subjects who will receive bilateral superficial cervical plexus block is the interventional group whereas subjects who will receive local infiltration of lidocaine 2% is the control group. Before, during, and after the procedure, all subjects are monitored (blood pressure, heart rate, respiratory rate, and electrocardiography). Monitoring data, including pain, will be recorded. Pain is measured by using visual analog scale or verbal numeric rating scale. Arterial blood sample (approximately 3 cc) from each subject will be withdrawn twice and put into tubes containing anticoagulant for substance-P examination. Initial withdrawal is done before the anesthetics are given while the last one is done after the tracheostomy procedure. Before the procedure, location for incision and block will be marked. Interventional group will be given 10 mL of Bupivacaine 0.5% on each side of the neck (as marked) by using 20 mL spuit with 25 G 1.5 inch needle whereas control group will be given 4 mL of Lidocaine 2% on incisional region (as marked) by using 5 mL spuit with 25 G 1.5 inch needle. 1 mg of Midazolam can be given intravenously before the block if there is no contraindication. Tracheostomy will be performed 15 minutes after the block is administered or local infiltration has worked. After tracheostomy, patients will be continually monitored in post-anesthesia care unit while their blood samples will be delivered to laboratory for ELISA test.
Interventions
PROCEDUREAnalgesic Technique
Patients undergoing tracheostomy procedure must be administered with analgesics, such Lidocaine 20% or Bupivacaine 0.5%
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Physical Status ASA 1-3
Exclusion criteria
* Pregnant * Blood clotting disorder * Allergic to anesthetics (Lidocaine, Bupivacaine) used in this study * Local infection on procedure area * Deformity on procedure area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of substance-P (Baseline) | 3 months | Substance-P level is measured as a pain indicator. |
| Concentration of substance-P (After Tracheostomy) | 3 months | Substance-P level is measured as a pain indicator. |
Countries
Indonesia
Outcome results
None listed