Efficacy of Bilateral Superficial Cervical Plexus Block vs. Local Infiltration of Lidocaine 2% in Tracheostomy Procedure

Study Overview
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Brief Summary
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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
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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 Arterial blood sample (approximately 3 cc) from each subject will be withdrawn twice and put into tubes containing anticoagulant for substance-P examination.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.

Official Title
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Comparison of Efficacy Between Bilateral Superficial Cervical Plexus Block and Local Infiltration of Lidocaine 2% in Patients Undergoing Tracheostomy

Conditions
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Tracheostomy

Intervention / Treatment
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* Procedure: Analgesic Technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bilateral superficial cervical plexus block with Bupiv<br>Patients, who will have tracheostomy procedure, might receive bilateral superficial cervical plexus block with 10 mL of Bupivacaine 0.5% (20 mL spuit with 25 G 1.5 inch needle) on each side before tracheostomy procedure. | Procedure: Analgesic Technique<br>* Patients undergoing tracheostomy procedure must be administered with analgesics, such Lidocaine 20% or Bupivacaine 0.5%<br>|
| Active Comparator: Local infiltration of Lidocaine 2%<br>Patients, who will have tracheostomy procedure, might receive local infiltration of Lidocaine 2% (5 mL spuit with 25 G 1.5 inch needle) before tracheostomy procedure. | Procedure: Analgesic Technique<br>* Patients undergoing tracheostomy procedure must be administered with analgesics, such Lidocaine 20% or Bupivacaine 0.5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of substance-P (Baseline) | Substance-P level is measured as a pain indicator. | 3 months | 
| Concentration of substance-P (After Tracheostomy) | Substance-P level is measured as a pain indicator. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local infiltration, bilateral superficial cervical plexus block, lidocaine, bupivacaine, substance-p