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

Not Applicable

Completed

• Conditions: Tracheostomy
• Interventions: Procedure: Analgesic Technique

• Registration Number: NCT04006639
• Lead Sponsor: Indonesia University

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Arterial blood sample (approximately 3 cc) from each subject will be withdrawn twice and put into tubes containing anticoagulant for substance-P examination.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

Study Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Study Start: 2019-08-01
• Primary Completion: 2019-11-01
• Status Verified: 2019-12
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-30
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral superficial cervical plexus block with Bupiv	Analgesic Technique	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.
Local infiltration of Lidocaine 2%	Analgesic Technique	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia